Energy IntakeNCT05417659
Glycogen and Appetite
A study testing Exercise plus carbohydrate and Exercise plus niacin in people with Energy Intake, run by University of Bath at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Intake
- What is being tested?
- Exercise plus carbohydrate and Exercise plus niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
Official title: 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.
- Conditions
- Energy Intake
- Being tested
- Exercise plus carbohydrate, Exercise plus niacin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise plus carbohydrateDietary supplement
A high carbohydrate drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Exercise plus niacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ad libitum energy intake
Difference between ad libitum energy intake (kcal) post exercise between trials
Measured: 2 hours post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start10 Oct 2022
- Primary completion15 Mar 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Energy IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Bradshaw, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417659
- Sponsor's protocol ID
- EIRA1-7142
- Status last verified
- Oct 2023
- First submitted
- 17 May 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bradshaw L, Moreno-Cabanas A, Spellanzon B, Hutchins K, Narang B, Collins AJ, Koumanov F, Betts JA, Gonzalez JT. Metabolic, endocrine and appetite responses to carbohydrate versus niacin ingestion during exercise in healthy females and males. J Nutr. 2026 Aug 7:101773. doi: 10.1016/j.tjnut.2026.101773. Online ahead of print.
PubMed 42567359Bradshaw L, Cabanas AM, Spellanzon B, Hutchins KM, Collins AJ, Buniam J, van der Stede T, Mallinson J, Tsintzas K, Derave W, Walhin JP, Betts JA, Koumanov F, Gonzalez JT. Isolating the effects of carbohydrate and lipid availability on exercise-induced skeletal muscle signalling in males. J Physiol. 2026 Jan;604(1):267-281. doi: 10.1113/JP289864. Epub 2025 Nov 16.
PubMed 41243363
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Suppression of Adipose Lipolysis on GLP-1 and Energy Intake in Men and Women
- ClinicalTrials.gov ID
- NCT05417659
- Acronym / sponsor ID
- EIRA1-7142
- Conditions
- Energy Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboA 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 comparator | Dietary Supplement: Exercise plus carbohydrateA 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 | Experimental | Dietary Supplement: Exercise plus niacinA 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise plus carbohydrateA high carbohydrate drink to be consumed 1 hour prior to exercise and every 15 minutes during exercise. | Dietary supplement | Exercise plus carbohydrate |
| Exercise plus niacinA dose of niacin to be consumed 30 minutes prior to exercise, at onset of exercise and 30 minutes into exercise. | Dietary supplement | Exercise plus niacin |
| PlaceboA 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 | Control |
Primary outcome
Difference in ad libitum energy intake
Time frame: 2 hours post exercise
Difference between ad libitum energy intake (kcal) post exercise between trials
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 42567359Bradshaw L, Moreno-Cabanas A, Spellanzon B, Hutchins K, Narang B, Collins AJ, Koumanov F, Betts JA, Gonzalez JT. Metabolic, endocrine and appetite responses to carbohydrate versus niacin ingestion during exercise in healthy females and males. J Nutr. 2026 Aug 7:101773. doi: 10.1016/j.tjnut.2026.101773. Online ahead of print.
- Derived from this study: PubMed 41243363Bradshaw L, Cabanas AM, Spellanzon B, Hutchins KM, Collins AJ, Buniam J, van der Stede T, Mallinson J, Tsintzas K, Derave W, Walhin JP, Betts JA, Koumanov F, Gonzalez JT. Isolating the effects of carbohydrate and lipid availability on exercise-induced skeletal muscle signalling in males. J Physiol. 2026 Jan;604(1):267-281. doi: 10.1113/JP289864. Epub 2025 Nov 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise plus carbohydrate and Exercise plus niacin in people with Energy Intake, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in ad libitum energy intake (time frame: 2 hours post exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05417659, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.