Glycogen and Appetite

Energy Intake Clinical Trial

Official title:

The Effect of Suppression of Adipose Lipolysis on GLP-1 and Energy Intake in Men and Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417659
• Other study ID #: EIRA1-7142
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2023
• Source: University of Bath
• Contact: Louise Bradshaw
• Phone: 000000
• Email: lb2311[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Energy Intake

Intervention

Dietary Supplement:
• Exercise plus carbohydrate
A high carbohydrate drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise.
• Exercise plus niacin
A dose of niacin to be consumed 30 minutes prior to exercise, at onset of exercise and 30 minutes into exercise.

Other:
• Placebo
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.

Locations

Country	Name	City	State
United Kingdom	Department for Health, University of Bath	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plasma GLP-1 concentrations post exercise	Incremental area under the curve of plasma GLP-1 concentrations	2 hours
Other	Change in plasma leptin concentrations post exercise	Incremental area under the curve of plasma leptin concentrations	2 hours
Other	Change in plasma insulin concentrations during exercise	Incremental area under the curve for plasma insulin concentrations	1 hour
Other	Change in plasma non-esterified fatty acid concentrations during exercise	Incremental area under the curve for plasma non-esterified fatty acid concentrations	1 hour
Other	Change in plasma glucose concentrations during exercise	Incremental area under the curve for plasma glucose concentrations	1 hour
Other	Change in plasma lactate concentrations during exercise	Incremental area under the curve for plasma lactate concentrations	1 hour
Other	Change in carbohydrate oxidation during exercise	Incremental area under the curve for carbohydrate oxidation	1 hour
Other	Change in fat oxidation during exercise	Incremental area under the curve for fat oxidation	1 hour
Other	Change in skin temperature during exercise	Incremental area under the curve for skin temperature	1 hour
Other	Change in core body temperature during exercise	Incremental area under the curve for core body temperature	1 hour
Other	Muscle glycogen utilisation	Difference in muscle glycogen utilisation during exercise between conditions	1 hour
Other	Extra-muscular glycogen oxidation	Difference in extra muscular glycogen oxidation during exercise between conditions	1 hour
Other	Difference in blood pressure between conditions	Difference in blood pressure between conditions	3 hours
Primary	Difference in ad libitum energy intake	Difference between ad libitum energy intake (kcal) post exercise between trials	2 hours post exercise