Investigating in Humans the Impact of Training Status on Dietary Consumption With Direct Measurement of Ingestive Behaviour

NCT07082582 | Recruiting

• 1 other identifier: 2024-00926
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the research project is to investigate the influence of training status on ingestive behavior and postprandial physiological responses in the human body. The investigators aim to understand how regular training influences the choice and amount of food consumed, as well as the associated physiological processes, including changes in the spectrum of gut hormones. The investigators are particularly interested in how these factors differ between individuals who train regularly compared to those who do not follow a structured training program. The research project aims to translate findings from previous animal experiments to humans and to examine whether and how training affects food handling and physiological responses, similar to observations made in rodents. This information could significantly contribute to improving recommendations for diet and physical activity in the population.

Conditions

Food Intake Regulation; Training Status

Keywords

Ingestive behavior; Gut Hormones; Drinkometer

Outcome Measures

Primary Outcomes (15)

• Energy Intake from Liquid Meal Consumption

  Total energy intake (in kilocalories) from consumption of high-carbohydrate, high-sucrose, and high-fat lactose-free milk during each visit. Intake is measured using a drinkometer device that quantifies the exact volume consumed, which is then converted into kilocalories based on the known energy density of each meal type. The unit of measure is kilocalories (kcal).

  From enrolment to the end of the study participation through four study visits within three months.

• Macrostructure of Ingestive Behavior (Rate of Energy Intake)

  The rate of energy intake is calculated for each participant during the ingestion of each of the three test stimuli, based on standardized measurements from the drinkometer system. This measure reflects the average caloric intake per second over the course of the test stimulus consumption. Energy intake is determined by the volume of liquid consumed, multiplied by the known caloric density of the test stimulus, and divided by the duration of the ingestion period. The unit of measure is kilocalories per second (kcal/s). This outcome is assessed during the first three study visits, in which a single test stimulus is administered at each visit. It is not measured during the fourth study visit, where all three test stimuli are presented simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months

• Macrostructure of Ingestive Behavior (Meal Duration)

  Meal duration is defined as the total time taken by each participant to consume each of the three test stimuli, measured using the standardized drinkometer system. For each stimulus, the duration is recorded from the initiation of ingestion (first measurable suck) to the completion of consumption (last measurable suck). The unit of measure is seconds (s). This outcome is assessed during the first three study visits, each involving the administration of a single test stimulus. Meal duration is not measured during the fourth study visit, where all three test stimuli are offered to participants simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Macrostructure of Ingestive Behavior (Number of Sucks)

  The primary outcome is the number of sucks performed by each participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "suck" is defined as a discrete negative pressure event generated by the participant to draw in liquid, as detected by the drinkometer's calibrated weight sensors. For each stimulus, the total number of sucks is recorded as a simple count, with the unit of measure being "number (n)." The outcome is assessed during the first three study visits, each of which features a single test stimulus administered in a standardized fashion. This outcome is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously to the participant.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Suck Energy Intake)

  Suck energy intake is defined as the total amount of energy (in kilocalories) consumed by the participant during each individual suck, measured for each of the three test stimuli using a standardized drinkometer system. For each test stimulus, the total caloric intake is calculated by multiplying the volume of liquid ingested by its caloric density and summing the values across all measured sucks. The unit of measure is kilocalories (kcal). This outcome is assessed during the first three study visits, where each visit involves a single test stimulus. Suck energy intake is not measured during the fourth study visit, in which all three test stimuli are presented to the participant simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Suck Duration)

  Suck duration is defined as the time span of each individual suck performed by the participant during the ingestion of each of the three test stimuli, as measured by a standardized drinkometer system. For each test stimulus, the duration of every suck is recorded from the initiation to the completion of the negative pressure event. The unit of measure is seconds (s). This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Suck duration is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Suck Rate)

  Suck rate is defined as the average energy intake of liquid ingested per second during each individual suck, measured for each of the three test stimuli using a standardized drinkometer system. For each test stimulus, the energy intake consumed during each suck is divided by the corresponding suck duration to determine the rate of ingestion for that event. The unit of measure is kilocalories per second (kcal/s). This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Suck rate is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Suck Maximal Rate)

  Suck maximal rate is defined as the highest instantaneous rate of liquid ingestion (in kilocalories per second) achieved during any single suck by the participant for each of the three test stimuli, as measured using a standardized drinkometer system. For each test stimulus, the maximal rate is determined by identifying the suck with the greatest energy intake per unit time among all measured sucks during the ingestion period. The unit of measure is kilocalories per second (kcal/s). This outcome is assessed during the first three study visits, with each visit involving a single test stimulus. Suck maximal rate is not measured during the fourth study visit, where all three test stimuli are presented simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Burst Number)

  Burst number is defined as the total count of distinct bursts performed by the participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of successive sucks separated by brief pauses, typically reflecting a rhythmic drinking pattern. For each test stimulus, the number of such bursts is recorded as an integer value. The unit of measure is "number of bursts" (n). This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Burst number is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Burst Duration)

  Burst duration is defined as the total elapsed time of each individual burst performed by the participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the duration is measured from the onset of the first suck to the end of the last suck within the burst. The unit of measure is seconds (s). This outcome is assessed during the first three study visits, with each visit involving a single test stimulus. Burst duration is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Burst Energy Intake)

  Burst energy intake is defined as the total amount of energy intake (in kilocalories) consumed during each individual burst by the participant, measured for each of the three test stimuli using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the energy intake is calculated by multiplying the volume of liquid ingested within the burst by the energy density of the test stimulus. The unit of measure is kilocalories (kcal). This outcome is assessed during the first three study visits, each involving a single test stimulus. Burst size is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Burst Rate)

  Burst rate is defined as the average rate of energy intake during each individual burst performed by the participant for each of the three test stimuli, as measured using a standardized drinkometer system. For each burst, the total energy intake (in kilocalories) is divided by the duration of the burst (in seconds) to determine the average rate of energy intake for that burst. The unit of measure is kilocalories per second (kcal/s). This outcome is assessed during the first three study visits, each involving a single test stimulus. Burst rate is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Number of Sucks per Burst)

  Number of sucks per burst is defined as the average count of individual sucks occurring within each burst during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the total number of sucks is recorded, and the outcome is typically reported as the mean number of sucks per burst. The unit of measure is "number of sucks per burst" (n). This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Number of sucks per burst is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Inter-Burst Intervals)

  Inter-burst interval is defined as the elapsed time between the end of one burst and the onset of the subsequent burst during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. The inter-burst interval quantifies the temporal spacing between bursts and is recorded in seconds (s). This outcome is assessed during the first three study visits, each involving a single test stimulus. Inter-burst intervals are not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

• Microstructure of Ingestive Behavior (Inter-Sucks Intervals)

  Inter-suck interval is defined as the elapsed time between the end of one suck and the initiation of the subsequent suck during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "suck" is operationally defined as a discrete negative pressure event corresponding to the drawing in of liquid. The inter-suck interval quantifies the temporal spacing between individual sucks within a burst or throughout the test stimulus consumption, and is recorded in seconds (s). This outcome is assessed during the first three study visits, each involving a single test stimulus. Inter-suck intervals are not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.

  From enrolment to the end of the study participation through three of four study visits within three months.

Secondary Outcomes (17)

• Plasma GLP-1 Concentration

  Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

• Plasma GIP Concentration

  Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

• Plasma Amylin Concentration

  Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

• Plasma PYY Concentration

  Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

• Plasma Ghrelin Concentration

  Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.

Study Arms (2)

Participants with trained Status

Trained status: continuous participation in a structured training program for at least the past six months, in addition to meeting the minimum requirement of physical activity of 150 min of moderate physical activity or 75 min of vigorous physical activity per week.

Participants with untrained Status

Untrained status: No participation in any structured training program for the last six months, in addition to not performing physical activity above 150 min of moderate physical activity or 75 min of vigorous physical activity per week.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants in the trained group are recruited from a rowing club affiliated with the University of Zürich (UZH) and Federal Technical institute of Zürich (ETH). Participants in the untrained group are recruited from students and employees of UZH and ETH.

You may qualify if:

• Training status classified as "trained" or "untrained",
• Chronological age ≥ 18 and ≤ 35,
• Body Mass Index ≥ 18.5 and ≤ 26,
• Current enrolment in a university,
• Language: English or German, with a sufficient English proficiency to fill out the food questionnaire,
• Ability and willingness to participate in the study, and
• Voluntarily signed informed consent.

You may not qualify if:

• History of previous metabolic and bariatric surgery,
• Current use of medications for medical treatment (excluding contraceptive measures),
• Current use of over-the-counter medications for weight loss or appetite control,
• Current medical diagnosis of metabolic disorders (such as type
• or 2 diabetes mellitus),
• Use of antibiotics in the last two months,
• History of use of probiotics (excluding yogurt and sauerkraut),
• Smoking,
• Biological or surgical menopause,
• Polycystic ovary syndrome (PCOS),
• Pregnancy, lactation, or current attempt of conception, and
• History of chronic substance abuse.

Sponsors & Collaborators

• Michele Serra: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (20)

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• Strasser B, Wolters M, Weyh C, Kruger K, Ticinesi A. The Effects of Lifestyle and Diet on Gut Microbiota Composition, Inflammation and Muscle Performance in Our Aging Society. Nutrients. 2021 Jun 15;13(6):2045. doi: 10.3390/nu13062045.

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• Sondergaard Nielsen M, Rasmussen S, Just Christensen B, Ritz C, le Roux CW, Berg Schmidt J, Sjodin A. Bariatric Surgery Does Not Affect Food Preferences, but Individual Changes in Food Preferences May Predict Weight Loss. Obesity (Silver Spring). 2018 Dec;26(12):1879-1887. doi: 10.1002/oby.22272. Epub 2018 Nov 13.

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• Serra M, File B, Alceste D, Raguz I, Gero D, Thalheimer A, Widmer J, Ismaeil A, Steinert RE, Spector AC, Bueter M. Burst-pause criterion derivation for drinkometer measurements of ingestive behavior. MethodsX. 2022 May 11;9:101726. doi: 10.1016/j.mex.2022.101726. eCollection 2022.

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• Quiroga R, Nistal E, Estebanez B, Porras D, Juarez-Fernandez M, Martinez-Florez S, Garcia-Mediavilla MV, de Paz JA, Gonzalez-Gallego J, Sanchez-Campos S, Cuevas MJ. Exercise training modulates the gut microbiota profile and impairs inflammatory signaling pathways in obese children. Exp Mol Med. 2020 Jul;52(7):1048-1061. doi: 10.1038/s12276-020-0459-0. Epub 2020 Jul 6.

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• Mathes CM, Letourneau C, Blonde GD, le Roux CW, Spector AC. Roux-en-Y gastric bypass in rats progressively decreases the proportion of fat calories selected from a palatable cafeteria diet. Am J Physiol Regul Integr Comp Physiol. 2016 May 15;310(10):R952-9. doi: 10.1152/ajpregu.00444.2015. Epub 2016 Feb 10.

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• Gero D, File B, Alceste D, Frick LD, Serra M, Ismaeil AE, Steinert RE, Spector AC, Bueter M. Microstructural changes in human ingestive behavior after Roux-en-Y gastric bypass during liquid meals. JCI Insight. 2021 Aug 9;6(15):e136842. doi: 10.1172/jci.insight.136842.

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• Gero D, Bueter M. Post-bariatric changes in ingestive behavior: Shift in macronutrient preferences in rats and dynamic adaptation of the within-meal microstructure in humans. Physiol Behav. 2023 May 1;263:114113. doi: 10.1016/j.physbeh.2023.114113. Epub 2023 Feb 8.

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• Dohnalova L, Lundgren P, Carty JRE, Goldstein N, Wenski SL, Nanudorn P, Thiengmag S, Huang KP, Litichevskiy L, Descamps HC, Chellappa K, Glassman A, Kessler S, Kim J, Cox TO, Dmitrieva-Posocco O, Wong AC, Allman EL, Ghosh S, Sharma N, Sengupta K, Cornes B, Dean N, Churchill GA, Khurana TS, Sellmyer MA, FitzGerald GA, Patterson AD, Baur JA, Alhadeff AL, Helfrich EJN, Levy M, Betley JN, Thaiss CA. A microbiome-dependent gut-brain pathway regulates motivation for exercise. Nature. 2022 Dec;612(7941):739-747. doi: 10.1038/s41586-022-05525-z. Epub 2022 Dec 14.

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• Borer KT, Lin PJ, Wuorinen E. Timing of Meals and Exercise Affects Hormonal Control of Glucoregulation, Insulin Resistance, Substrate Metabolism, and Gastrointestinal Hormones, but Has Little Effect on Appetite in Postmenopausal Women. Nutrients. 2021 Dec 1;13(12):4342. doi: 10.3390/nu13124342.

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• Alceste D, Serra M, Raguz I, Gero D, Thalheimer A, Widmer J, File B, Ismaeil A, Steinert RE, Spector AC, Bueter M. Association between microstructure of ingestive behavior and body weight loss in patients one year after Roux-en-Y gastric bypass. Physiol Behav. 2022 May 1;248:113728. doi: 10.1016/j.physbeh.2022.113728. Epub 2022 Feb 5.

  PMID: 35134394 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected from venous blood before, directly after, and 30 minutes after the meal test. Plasma samples will be isolated from blood samples and stored at -80° C for later analysis. The analysis of DNA is not planned in this study. Nevertheless, plasma can contain cell-free DNA (cfDNA). Considering that no solution for the stabilisation of nucleic acid is added to the plasma samples, a complete or meaningful sequencing of the cfDNA can hardly be expected from the plasma samples collected in this study. Stool samples are collected at two different time points to establish the circadian rhythm of the gut microbiome. Metagenomics and metatranscriptomics analysis will be performed only on microbial genetic material.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Central Study Contacts

Michele Serra, PhD

CONTACT

+41 76 222 67 63; michele.serra@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 24, 2025
• Study Start: October 29, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)