- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05417659
Glycogen and Appetite
March 24, 2025 updated by: Louise Bradshaw, University of Bath
The Effect of Suppression of Adipose Lipolysis on GLP-1 and Energy Intake in Men and Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bath, United Kingdom, BA2 7AY
- Department for Health, University of Bath
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
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.
|
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.
|
|
Active Comparator: Exercise plus carbohydrate
A 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.
|
A high carbohydrate drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise.
|
|
Experimental: Exercise plus niacin
A 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.
|
A dose of niacin to be consumed 30 minutes prior to exercise, at onset of exercise and 30 minutes into exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in ad libitum energy intake
Time Frame: 2 hours post exercise
|
Difference between ad libitum energy intake (kcal) post exercise between trials
|
2 hours post exercise
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plasma GLP-1 concentrations post exercise
Time Frame: 2 hours
|
Incremental area under the curve of plasma GLP-1 concentrations
|
2 hours
|
|
Change in plasma leptin concentrations post exercise
Time Frame: 2 hours
|
Incremental area under the curve of plasma leptin concentrations
|
2 hours
|
|
Change in plasma insulin concentrations during exercise
Time Frame: 1 hour
|
Incremental area under the curve for plasma insulin concentrations
|
1 hour
|
|
Change in plasma non-esterified fatty acid concentrations during exercise
Time Frame: 1 hour
|
Incremental area under the curve for plasma non-esterified fatty acid concentrations
|
1 hour
|
|
Change in plasma glucose concentrations during exercise
Time Frame: 1 hour
|
Incremental area under the curve for plasma glucose concentrations
|
1 hour
|
|
Change in plasma lactate concentrations during exercise
Time Frame: 1 hour
|
Incremental area under the curve for plasma lactate concentrations
|
1 hour
|
|
Change in carbohydrate oxidation during exercise
Time Frame: 1 hour
|
Incremental area under the curve for carbohydrate oxidation
|
1 hour
|
|
Change in fat oxidation during exercise
Time Frame: 1 hour
|
Incremental area under the curve for fat oxidation
|
1 hour
|
|
Change in skin temperature during exercise
Time Frame: 1 hour
|
Incremental area under the curve for skin temperature
|
1 hour
|
|
Change in core body temperature during exercise
Time Frame: 1 hour
|
Incremental area under the curve for core body temperature
|
1 hour
|
|
Muscle glycogen utilisation
Time Frame: 1 hour
|
Difference in muscle glycogen utilisation during exercise between conditions
|
1 hour
|
|
Extra-muscular glycogen oxidation
Time Frame: 1 hour
|
Difference in extra muscular glycogen oxidation during exercise between conditions
|
1 hour
|
|
Difference in blood pressure between conditions
Time Frame: 3 hours
|
Difference in blood pressure between conditions
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2022
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
August 30, 2024
Study Registration Dates
First Submitted
May 17, 2022
First Submitted That Met QC Criteria
June 12, 2022
First Posted (Actual)
June 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 27, 2025
Last Update Submitted That Met QC Criteria
March 24, 2025
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIRA1-7142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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