Glycogen and Appetite
The Effect of Suppression of Adipose Lipolysis on GLP-1 and Energy Intake in Men and Women
1 other identifier
interventional
15
1 country
1
Brief Summary
Obesity is the outcome of chronic excessive energy intake and reduced energy expenditure leading to energy imbalance. It is a risk factor for many preventable diseases such as metabolic disease and its consequences such as type 2 diabetes and cardiovascular disease. Sedentary adults have been shown to have an increased appetite in excess of energy requirements and adults who are more active are able to better regulate energy intake. It is thought that carbohydrate availability and specifically hepatic glycogen utilisation during exercise is a regulator of appetite. However, the majority of research so far does not support this theory, potentially due to research not examining the tissue-specific link between glycogen use and appetite. The aim of this study is to assess whether altering substrate utilisation during exercise by suppressing lipolysis influences GLP-1 levels and caloric intake post exercise. Additionally, the study will explore if there is a tissue specific link between substrate utilisation and post exercise energy intake and examine potential sex differences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedMarch 27, 2025
October 1, 2023
1.4 years
May 17, 2022
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in ad libitum energy intake
Difference between ad libitum energy intake (kcal) post exercise between trials
2 hours post exercise
Other Outcomes (13)
Change in plasma GLP-1 concentrations post exercise
2 hours
Change in plasma leptin concentrations post exercise
2 hours
Change in plasma insulin concentrations during exercise
1 hour
- +10 more other outcomes
Study Arms (3)
Control
PLACEBO COMPARATORA placebo drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise and placebo tablets to be consumed 30 minutes prior to exercise, at the onset of exercise and 30 minutes into exercise.
Exercise plus carbohydrate
ACTIVE COMPARATORA high carbohydrate drink (1.6g/kg) to be consumed 1 hour prior to exercise and further drinks (0.2g/kg) every 15 minutes during exercise.
Exercise plus niacin
EXPERIMENTALA dose of niacin (10mg/kg) to be consumed 30 minutes prior to exercise and two further doses (5mg/kg) at the onset of exercise and 30 minutes into exercise.
Interventions
A high carbohydrate drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise.
A dose of niacin to be consumed 30 minutes prior to exercise, at onset of exercise and 30 minutes into exercise.
A placebo drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise and placebo tablets to be consumed 30 minutes prior to exercise, at the onset of exercise and 30 minutes into exercise.
Eligibility Criteria
You may qualify if:
- Males aged 18-60 and premenopausal women
- Physically active (at least 30 minutes of exercise 3 times a week)
- Body mass index 18.0-30.0 kg·m-2
You may not qualify if:
- Weight instability (\>5kg change in body mass over last 6 months)
- Restrained eater (e.g. limiting food intake, calorie counting)
- Current smoker
- Aversion or allergy to test meal foods
- Pregnant or lactating
- Amenorrhoea in women
- Any medical condition or medication that could introduce bias into the study (e.g., diabetes, CVD, lipid or glucose metabolism altering medications)
- Any cardiopulmonary condition prohibiting exercise testing
- Any contraindication to niacin or aspirin (e.g., diabetes, gout, clotting disorders, allergy to non-steroidal anti-inflammatory drugs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department for Health, University of Bath
Bath, BA2 7AY, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
May 17, 2022
First Posted
June 14, 2022
Study Start
October 10, 2022
Primary Completion
March 15, 2024
Study Completion
August 30, 2024
Last Updated
March 27, 2025
Record last verified: 2023-10