Effects of Calorie Restriction and Cold Stimuli on Health-related Indicators, Cognitive and Motor Functions

NCT05545943 | Completed

• 1 other identifier: LithuanianSportsU-10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to identify if duration of acute calorie restriction (CR)/fasting or combination CR with cold stimuli have any effects on mental and physical health-related markers, and to clarify if different fasting strategies have any effect on cognitive and motor functioning efficiency in different genders. The main questions it aims to answer were:

• Does fasting duration have any effect on fasting evoked responses?
• Does cold interventions can modulate fasting evoked responses?
• Does sex have any effect on acute fasting evoked responses? For the first part, participants were randomly classified into 4 groups: two experimental groups: 2-days of CR (0 kcal diet) and 6-days of CR (0 kcal diet), and two control groups: 2-days or 6-days usual diet. For the second part, participants were randomly assigned to undergo the following conditions: 2-days of CR with two 10-min whole-body cold-water immersions on separate days, 2-days of CR without cold-water immersion, 2-days without CR with two 10-min whole-body cold-water immersions on separate days, or 2-days of the usual diet without cold-water immersion in a randomized crossover fashion. Changes in anthropometric characteristics, perceived stress, metabolism, overall health (total blood count, sex hormones, etc.), psycho-emotional state, cognitive and motor functions were examined.

Conditions

Calorie Deficiency; Fasting; Cold Exposure

Keywords

cognition; motor function; metabolism; young adults; fasting; starvation; men; women; calorie deprivation; stress; kynurines; catecholamines; glucose tolerance; energy expenditure; weight loss

Outcome Measures

Primary Outcomes (50)

• Change in body mass and body composition (kg)

  Body mass and composition (in kg) was evaluated using Tanita Body Composition Analyzer (Japan).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in body mass index (kg/m2)

  The body mass index (in kg/m2) was defined as the body mass divided by the square of the body height.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in substrate oxidation

  Oxygen consumption and carbon dioxide output every 5 s on a breath-by breath basis using an Oxycon Mobile spirometry system (Oxygen Mobile, Jaeger/ VIASYS Healthcare, Germany) was measured at rest, and the respiratory quotient (RQ=VCO2/VO2) was computed to determine substrate utilisation. The RQ values for fat was assumed as 0.7, for protein was assumed as 0.8 and for carbohydrate was assumed as 1.0.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in energy expenditure (kcal/day)

  Resting energy expenditure (REE) using Weir equation modified Weir equation: REE (kcal/day)=\[3.941(oxygen consumption) + 1.106(carbon dioxide output)\] x 1440

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in body temperature (°C)

  Rectal temperature (°C) was measured using a thermocouple (Rectal Probe, Ellab, Denmark) inserted to a depth of 12 cm past the anal sphincter, skin temperature (°C) was measured with thermistors (Skin/Surface Probe, DM852, Ellab) at three sites: back, thigh, and forearm, and right lateral gastrocnemius muscle temperature (°C) was measured using a needle microprobe (MKA; Ellab).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in heart rate variability (ms)

  R-R intervals (in ms) in supine resting conditions were recorded using a Polar HR sensor (Finland) and and simultaneously transferred to Polar Pro Trainer 5 software (Finland).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in heart rate variability (time domain) (ms)

  Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the time domain that reflects general heart rate variability (HRV), the standard deviation of normal-to-normal intervals (SDNN; estimate of overall HRV) and the root mean square of successive differences (RMSSD; estimate of short-term components of HRV) were assessed (in ms).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in heart rate variability (time domain) (Ln)

  Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the time domain that reflects general heart rate variability (HRV), the standard deviation of normal-to-normal intervals (SDNN; estimate of overall HRV) and the root mean square of successive differences (RMSSD; estimate of short-term components of HRV) were assessed and logarithmically transformed (Ln) to correct the skewness of distribution.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in heart rate variability (frequency domain) (ms2)

  Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers in absolute units (in ms2).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in heart rate variability (frequency domain) (Ln)

  Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers were assessed and logarithmically transformed (Ln) to correct the skewness of distribution.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in heart rate variability (frequency domain) (nu)

  Heart rate variability data were analyzed using Kubios HR Variability Analysis software (Finland). In the frequency domain that measures the more specific contribution of the autonomic nervous system branch, we used the fast Fourier transform to assess low-frequency (LF; estimates sympathetic and parasympathetic activity) and high-frequency (HF; estimates parasympathetic activity) powers in normalized units (in nu).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in heart rate (bpm)

  Heart rate (in bpm) was recorded using a heart rate sensor with a chest strap (Polar, Finland) in laying position at rest.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in blood pressure (mmHg)

  Resting systolic and diastolic blood pressure (in mmHg) was measured using a digital electronic blood pressure monitor (Microlife, Switzerland)

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in perceived stress

  Perceived stress was evaluated with visual analog scales (VAS) ranging from 0 ("no stress") to 100 ("the highest stress imaginable").according to how participants feel "right now".

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in appetite sensations

  Appetite sensations (hunger and fullness) were evaluated with VAS ranging from 0 ("I am not hungry at all/not at all full") to 100 ("I have never been more hungry/totally full") according to how participants feel "right now".

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in mood state

  Mood state was evaluated with Brunel mood scale according to how participants feel "right now". The scale consists of 24 items divided into six subscales: anger, confusion, depression, fatigue, tension, and vigor. The items are answered on a 5-point scale, and each subscale, with four relevant items, are summed to produce a raw score in the range of 0-16, where a higher score indicates greater endorsement of the specific mood state.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in venous complete blood count (10^9/L)

  Venous complete blood count with 5 different white blood count (WBC) components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in 10\^9/L) was performed using an automated Mythic 60 hematology analyzer (Switzerland).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in venous complete blood count (%)

  Venous complete blood count with 5 different white blood count (WBC) components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in %) was performed using an automated Mythic 60 hematology analyzer (Switzerland).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in serum female sex hormones concentration (pg/mL)

  The venous serum 17beta-estradiol and progesterone (in pg/mL) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in serum female sex hormones concentration (mIU/ml)

  The venous serum follicle stimulating and luteinizing hormones (in mIU/ml) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in serum brain-derived neurotrophic factor concentration (pg/ml)

  The venous serum brain-derived neurotrophic factor (in pg/ml) was measured using enzyme-linked immunosorbent assay kits (Cat.No. DBD00; R\&D Systems, Emeryville, USA) and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in serum interleukin-10 concentration (pg/ml)

  The venous serum interleukin (in pg/ml) was measured using enzyme-linked immunosorbent assay kits (Cat. No. 30147233; IBL International GmBH, Germany) and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in serum insulin concentration (μIU/ml)

  The venous serum insulin concentrations (in μIU/ml) were measured using enzyme-linked immunosorbent assay kits (Cat. No. E-EL-H2237, Elabscience, China) and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in serum glucagon concentration (pg/ml)

  The venous serum glucagon concentrations (in pg/ml) were measured using enzyme-linked immunosorbent assay kits (DIAsource ImmunoAssays S.A.,Belgium) and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in plasma catecholamines concentration (ng/ml)

  The venous plasma adrenaline and noradrenaline concentrations (in ng/ml) were measured using enzyme-linked immunosorbent assay kits (Cat. No. RE59242, IBL International GmbH, Germany) and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in plasma malondialdehyde concentration (nmol/ml)

  The venous plasma malondialdehyde concentrations (in nmol/l) were measured using a solid phase nzyme-linked immunosorbent assay (Cat. No. E1371Hu, Bioassay Technology Laboratory, Shangai, China) and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48, 84 and 144 hours post-condition, and 1 week after recovery

• Change in plasma total antioxidant capacity (mmol/l)

  The venous plasma total antioxidant capacitys (in mmol/l) were measured colorimetrically with an assay kit (Cat. No.E-BC-K271-M, Elabscience Biotechnology Inc, Houston, USA) and using a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48, 84 and 144 hours post-condition, and 1 week after recovery

• Change in venous glucose concentration (mmol/l)

  The venous glucose concentration (in mmol/l) was measured in venous blood samples using a Glucocard X-mini plus glucose analyser (Arkray, Japan).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in insulin sensitivity

  An oral glucose insulin sensitivity \[OGIS\] index derived from an oral glucose tolerance test was calculated.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in plasma metabolites of the kynurenine pathway (μm)

  An ultra-performance liquid chromatography-tandem mass spectrometry system (UPLC-MS/MS) to measure venous plasma levels of tryptophan, kynurenine, kynurenic acid, 3-hydroxy-kynurenine, quinolinic acid, nicotinamide and picolinic acid (in μm). The UPLC-MS/MS system used a Xevo TQ-XS triple quadrupole mass spectrometer (Waters) with a Z-spray electrospray interface, and the system was operated in electrospray positive multiple reaction monitoring mode.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in salivary cortisol concentration (µg/dl)

  The saliva samples were collected to measure cortisol level (in µg/dl) using a enzyme-linked immunosorbent assay (ELISA) kits and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in salivary testosterone concentration (µg/dl)

  The saliva samples were collected to measure testosterone level (in µg/dl) using a enzyme-linked immunosorbent assay (ELISA) kits and a Spark multimode microplate reader (Tecan, Austria).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in capillary lipid profile (mmol/l)

  The capillary blood samples were collected from finger to measure lipid profile (in mmol/l) (total cholesterol, high density and low density cholesterol, triglycerides) using a CardioChek PA analyzer (USA).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in manual dexterity performance (sec)

  The Grooved Pegboard was used to evaluate the ability to coordinate the fingers and manipulate objects promptly in time twice (in sec).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in information processing (μV)

  Using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany), event-related potentials (ERPs) during oddball tasks by two modalities (auditory and visual) were recorded. Peak amplitudes (μV) of the N1, N2 and P3 at three sites (Fz, Cz, and Pz) were defined.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in information processing (ms)

  Using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany), event-related potentials (ERPs) during oddball tasks by two modalities (auditory and visual) were recorded. Latencies (ms) of the N1, N2 and P3 at three sites (Fz, Cz, and Pz) were defined.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in brain neural network activity (µV2)

  Resting electroencephalography was recorded using a 32-channel Standard Brain Cap (EasyCap GmbH, Germany). Participant's data were averaged across the epochs for Fz, Cz and Pz electrodes, and mean absolute power (in µV2) was computed for theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz) frequency band.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in cognitive performance (ms)

  Two oddball tasks were used in this study: in one task, visual stimuli were presented, and in the other task, auditory stimuli were presented. Reaction times (in ms) were measured.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in cognitive performance (%)

  Two oddball tasks were used in this study: in one task, visual stimuli were presented, and in the other task, auditory stimuli were presented. Accuracy of response to the target stimulus (in %) were measured.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in reflexes (mV)

  Soleus H-reflexes, V-waves and M-waves were evoked by 0.5 ms square-wave pulses using a high-voltage stimulator (Digitimer, UK). The amplitudes (in mV) of the electrical evoked reflexes were evaluated.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in reflexes (ms)

  Soleus H-reflexes, V-waves and M-waves were evoked by 0.5 ms square-wave pulses using a high-voltage stimulator (Digitimer, UK). The latencies (in ms) of the electrical evoked reflexes were evaluated.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in muscle activity (mV)

  Tibial muscles electromyographic (EMG) amplitude (in mV) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in muscle activity (Hz)

  Tibial muscles electromyographic (EMG) frequency (in Hz) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in voluntary torque (Nm)

  Isometric and isokinetic voluntary torques (in Nm) of the ankle plantar flexion/dorsiflexion muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA).

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in involuntary torque (Nm)

  Involuntary torque of the ankle plantar flexion muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA) and a high-voltage stimulator (Digitimer DS7A, Digitimer, UK). Peak torques (in Nm) induced by electrical stimulation at 20 Hz,at 100 Hz, and at TT100 were measured.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in muscle contraction and relaxation (ms)

  The contraction and half-relaxation time (in ms) were measured in resting TT100 contractions.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in central activation ratio (%)

  To evaluate central activation ratio (CAR), a TT-100 Hz stimuli was superimposed on the maximal voluntary contraction (MVC), and the CAR was computed using the following equation: CAR = MVC/(MVC+TT-100 Hz) × 100%, where where a CAR of 100% indicates complete activation of the exercising muscle and a CAR \< 100% indicates central activation failure or inhibition.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in reactive strength

  The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate reactive-strength. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Reactive strength index as jump height / time to take off was calculated.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in jump performance (cm)

  The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate jump performance. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Jump height (in cm) height was evaluated.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in jump performance (m/s)

  The drop jump test on a force mobile platform (AccuPower, AMTI, USA) was used to evaluate jump performance. Jumps were performed while holding the hands of the subject on the hips were requested jump as fast as possible after the drop off from the platform and make sure that the jump is the highest possible. Time to take off (in m/s) was evaluated.

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

Secondary Outcomes (8)

• Change in height (m)

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in skinfold thickness (mm)

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in body fatness (%)

  Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery

• Change in physical activity (Step count)

  3 days before condition, during 48 or 144 hours of interventions and during 1 week post-condition. (2 weeks)

• Change in sleep (h)

  3 days before condition, during 48 or 144 hours of interventions and during 1 week post-condition. (2 weeks)]

Study Arms (6)

2-days of calorie restriction with whole body cooling

EXPERIMENTAL

Healthy young subjects participated in a 2-day CR (0 kcal with water provided ad libitum ) with two 10-min whole body cooling practices on separate days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data.

Other: 2-days of zero calorie restriction and whole-body cold-water immersion

6-days of calorie restriction

EXPERIMENTAL

Healthy young subjects participated in 6-day CR (0 kcal with water provided ad libitum). All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data.

Other: 6-days of calorie restriction

2-days of the usual diet (control)

NO INTERVENTION

During the control trial, the healthy young subjects were instructed to maintain their previous eating habits for 2 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data.

6 days of the usual diet (control)

NO INTERVENTION

During the control trial, the healthy young subjects were instructed to maintain their previous eating habits for 6 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data.

2-days of calorie restriction without whole-body cooling

EXPERIMENTAL

Healthy young subjects participated in a 2-day CR (0 kcal with water provided ad libitum ) without whole body cooling. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data.

Other: 2-days of zero calorie restriction without whole-body cold-water immersion

2-days of usual diet with whole-body cooling

ACTIVE COMPARATOR

Healthy young subjects participated two 10-min whole body cooling practices on separate days and were instructed to maintain their previous eating habits for 6 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data.

Other: 2-days of usual diet with whole-body cold-water immersion

Interventions

2-days of zero calorie restriction and whole-body cold-water immersion OTHER

The 2-days (48 hours) of zero-calorie restricted diet (with water provided ad libitum) with two whole-body cold-water immersion sessions on separate days. During cooling procedures, the participant was immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 10 min.

2-days of calorie restriction with whole body cooling

6-days of calorie restriction OTHER

The 6-days (144 hours) of prescribed zero-calorie prescribed diet with water provided ad libitum.

6-days of calorie restriction

2-days of zero calorie restriction without whole-body cold-water immersion OTHER

2 days (48 hours) of prescribed zero-calorie diet with water provided ad libitum .

2-days of calorie restriction without whole-body cooling

2-days of usual diet with whole-body cold-water immersion OTHER

Two whole-body cold-water immersion sessions on separate days. During cooling procedures, the participant was immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 10 min. During intervention, participants were instructed to maintain their previous eating habits.

2-days of usual diet with whole-body cooling

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index 19.5-29.9 kg/m2,
• age 18-40 years,
• no excessive regular moderate or vigorous physical activity, i.e., ≥3 times per week,
• non-smokers,
• no medications that could affect the results of experiment,
• no history of any eating, oncological, metabolic, cardiovascular, skeletal, neuromuscular, pulmonary disorders or diseases, mental disabilities or conditions that could be worsened by exposure to acute cold (14°) water or fasting and affect experimental variables,
• no history of alcoholism or dependence on psychotropic drugs,
• no blood/needle phobia,
• no involvement in any temperature-manipulation program or extreme temperature exposure for ⩾3 months,

Sponsors & Collaborators

• Lithuanian Sports University: lead

Study Sites (1)

Lithuanian Sports University

Kaunas, Lithuania

Location

Related Publications (1)

• Solianik R, Zidoniene K, Baranauskiene N, Brazaitis M. Fasting for 48 h induced similar glucose intolerance in both sexes despite greater perceived stress and decreased estradiol levels in females. Eur J Appl Physiol. 2024 May;124(5):1449-1459. doi: 10.1007/s00421-023-05378-y. Epub 2023 Dec 18.

  PMID: 38108909 DERIVED

MeSH Terms

Conditions

Fasting; Starvation; Multiple Endocrine Neoplasia Type 1; Weight Loss

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katerina Židonienė

  Lithuanian Sports University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researchers who analyzed the saliva and venous blood samples were blinded to the experimental conditions.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project consisted of two parts. For the first part was used randomized parallel model, and we aimed to investigate fasting duration effect, whereas for the second part was used randomized crossover model and we aimed to investigate if cold exposure can modify fasting evoked effects on health-related indicators, cognition and motor function.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 19, 2022
• Study Start: February 8, 2021
• Primary Completion: September 5, 2022
• Study Completion: October 5, 2022
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)