The Effect of Butanediol Ingestion on Skeletal Muscle Angiogenesis in Hypoxia

NCT06472427 | Completed DMC

• 1 other identifier: S68402
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study specifically aims to elucidate the effects of intermittent exogenous ketosis (IEK) as well as hypoxia on muscular pro-angiogenic factors- after a 60-min HIIT bout in normoxia. Moreover, blood and muscle oxygenation status, as well as peripheral blood flow and cognitive function will be assessed.

Conditions

Ketosis; Hypoxia; Angiogenesis

Keywords

Exercise; Recovery; Living high training low

Outcome Measures

Primary Outcomes (2)

• Post-exercise muscle VEGF mRNA expression

  Measured using PCR on collected muscle biopsies

  Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.

• Post-exercise serum EPO concentrations

  Measured using ELISA on collected serum samples

  Venous blood samples are collected 10 minutes after the end of training as well as 3 hours, 5 hours and 7 hours later.

Secondary Outcomes (6)

• Change in muscular VEGF concentration

  Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.

• Change in serum VEGF concentration

  Venous blood samples are collected immediately (5 minutes) after the end of training, as well as 3hours, 5hours and 7hours later..

• Change in blood oxygenation

  Continuously measured starting 30 minutes after the end of exerciseuntil 7.5 hours later

• Change in skeletal muscle oxygenation

  Measured during resting measurements performed 30 minutes, 3hours and 30minutes as well as 6hours and 30minutes after the end of training.

• Change in peripheral blood flow

  Measured during resting measurements performed 30 minutes, 3hours and 30minutes as well as 6hours and 30minutes after the end of the training

Other Outcomes (1)

• Change in citrate synthase as a marker of mitochondrial density

  Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.

Study Arms (4)

1 session with normoxic post-exercise recovery, supplemented with placebo (NPL)

PLACEBO COMPARATOR

Normoxic training, followed by normoxic recovery with placebo supplements

Dietary Supplement: Normoxic recovery and placebo (NPL)

1 session with normoxic post-exercise recovery, supplemented with ketones (NKE)

EXPERIMENTAL

Normoxic training, followed by normoxic recovery with ketone supplements

Dietary Supplement: Normoxic recovery and ketones (NKE)

1 session with hypoxic post-exercise recovery, supplemented with placebo (HPL)

EXPERIMENTAL

Normoxic training, followed by hypoxic (simulated altitude of 3000m) recovery with placebo supplements

Dietary Supplement: Hypoxic recovery and placebo (HPL)

1 session with hypoxic post-exercise recovery, supplemented with ketones (HKE)

EXPERIMENTAL

Normoxic training, followed by hypoxic (simulated altitude of 3000m) recovery with ketone supplements

Dietary Supplement: Hypoxic recovery and ketones (HKE)

Interventions

Normoxic recovery and placebo (NPL) DIETARY_SUPPLEMENT

Altitude: sea level Dietary supplement: placebo. Water: 98.3% w/w Bitter flavour type: 0.7% w/w Monk fruit extract: 0.04% w/w Tasteva: 0.03% w/w Citric acid: 0.6% w/w Flavor blend: 0.02% w/w Bitter masking flavour: 0.2% w/w Passion fruit flavour: 0.005% w/w

1 session with normoxic post-exercise recovery, supplemented with placebo (NPL)

Normoxic recovery and ketones (NKE) DIETARY_SUPPLEMENT

Altitude: sea level Dietary supplement: Commercially available Ketone-IQ butanediol drink R-1,3-butanediol: 28.6% w/v in water

1 session with normoxic post-exercise recovery, supplemented with ketones (NKE)

Hypoxic recovery and placebo (HPL) DIETARY_SUPPLEMENT

Altitude: 3,000m (simulated) Dietary supplement: placebo. Water: 98.3% w/w Bitter flavour type: 0.7% w/w Monk fruit extract: 0.04% w/w Tasteva: 0.03% w/w Citric acid: 0.6% w/w Flavor blend: 0.02% w/w Bitter masking flavour: 0.2% w/w Passion fruit flavour: 0.005% w/w

1 session with hypoxic post-exercise recovery, supplemented with placebo (HPL)

Hypoxic recovery and ketones (HKE) DIETARY_SUPPLEMENT

Altitude: 3,000m (simulated) Dietary supplement: Commercially available Ketone-IQ butanediol drink R-1,3-butanediol: 28.6% w/v in water

1 session with hypoxic post-exercise recovery, supplemented with ketones (HKE)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent must be obtained prior to any experimental procedures
• Biological male or biological females using oral contraception between 18 and 35 years old
• Recreational or competitive cyclists performing regularly cycling training sessions with an average training volume of more than 6 hours per week
• Good health status confirmed by a medical screening
• Body Mass Index (BMI) between 18 and 25 kg/m2

You may not qualify if:

• Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise, evaluated by a sport medical screening
• Intake of any medication or nutritional supplement that is known to affect exercise or performance. Intake will be assessed during recruitment and the sport medical screening.
• Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, within two weeks of study participation.
• Recent residence or training under hypoxia; more than 7 days exposure to altitude \> 1500 m during the 3 months preceding the study.
• Blood donation within 3 months of study participation.
• Habitual smoking
• Pre-existing, diagnosed psychiatric conditions or anxiety
• Females that are pregnant or are planning to be pregnant before the end of the study (end of May 2024)
• Depression or anxiety as assessed by the Beck Depression Inventory 25 (Appendix 2) and Beck Anxiety Inventory 26 (Appendix 3). Only a score in the range of 'normal ups and downs' (score 1-10) for depression or 'minimal anxiety' (score 0-7) for anxiety are tolerated.
• History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire (Appendix 4).
• Any other reason that might pose undue risk to the participant, or introduce bias into the study outcomes, at the discretion of the research team.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Ketosis; Hypoxia; Motor Activity

Interventions

Ketones

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

• Chiel Poffé

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and investigators actively parttaking in the study are blinded. Participants are misinformed that all sessions will be hypoxic, in order to prevent identification of normoxic vs hypoxic conditions. Therefore, participants are also misinformed about the supplements, where they think they will receive 4 different compositions of ketones.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1 session with normoxic post-exercise recovery, supplemented with placebo (NPL) 1 session with normoxic post-exercise recovery, supplemented with ketones (NKE) 1 session with hypoxic post-exercise recovery, supplemented with placebo (HPL) 1 session with hypoxic post-exercise recovery, supplemented with ketones (HKE)

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 25, 2024
• Study Start: July 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)