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

Michele Serra

Status: Enrolling

Conditions: Training Status; Food Intake Regulation

Study type: Observational

Funder types: Other

Identifiers

NCT07082582

2024-00926

Details and patient eligibility

About

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.

Full description

The goal of the proposed research is to identify the differences in ingestive behavior that might be caused by the training status in humans after long-term structured exercise. For this, the investigators plan to investigate and cross-sectionally compare microstructural parameters of ingestive behavior between individuals with trained and untrained status when offered three different meals (high-carbohydrate, high-fat, high-sucrose lactose-free milk) separately or concurrently.

Furthermore, the investigators propose to explore a possible correlation between microstructural parameters of ingestive behavior and postprandial levels of several gut hormones, and to investigate the differences in the composition and activity of the gut microbiome between the two groups, especially in relation to the observed ingestive behavior. Finally, the investigators will investigate the relationship between ingestive behavior and body composition separately for the two groups.

The microstructure of ingestive behavior of both male and female individuals in relation to training status has never been investigated in a direct measurement approach before and the investigators of this project are the only one that currently have both the technical requirements as well as the necessary experience to carry out such studies.

The previous research project "Direct measurement of changes in food selection and intake behavior after RYGB surgery" (NCT04933305, NCT03747445) was successful. Although recruitment and retention of study participants was significantly hindered by the COVID-19 pandemic after March 2020, the investigators were able to publish four peer-reviewed scientific articles out of the proposed studies so far. Four additional manuscripts are currently in preparation.

The present research project builds logically on previous work in the field of bariatric surgery and builds a new collaborations with Prof. J. Nicholas Betley and Dr. Lavinia Boccia (University of Pennsylvania, USA). This collaboration will surely lead to relevant findings which will be published in at least two peer-reviewed publications.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

  1 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.

Trial design

60 participants in 2 patient groups

Participants with trained Status

Description:

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

Description:

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.