NCT05417659

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 27, 2025

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

May 17, 2022

Last Update Submit

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 COMPARATOR

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.

Other: Placebo

Exercise plus carbohydrate

ACTIVE COMPARATOR

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.

Dietary Supplement: Exercise plus carbohydrate

Exercise plus niacin

EXPERIMENTAL

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.

Dietary Supplement: Exercise plus niacin

Interventions

Exercise plus carbohydrateDIETARY_SUPPLEMENT

A high carbohydrate drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise.

Exercise plus carbohydrate
Exercise plus niacinDIETARY_SUPPLEMENT

A dose of niacin to be consumed 30 minutes prior to exercise, at onset of exercise and 30 minutes into exercise.

Exercise plus niacin
PlaceboOTHER

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.

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

ExerciseCarbohydratesNiacin

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

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

Locations