- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07476989
Effects of Dual-Source Carbohydrate Intake and Liver Glycogen Repletion After Overnight Fasting.
The Effects of a Dual-Source High-Carbohydrate Breakfast on Hepatic Glycogen Storage Following an Overnight Fast.
This study is looking at whether eating a breakfast which has two different sources of carbohydrates, glucose and fructose (found in foods like honey and fruits), can increase how much glycogen can be stored in the liver. Glucose is a type of sugar that the body uses to provide energy during exercise. When it is not circulating in the blood, it is stored in the muscles and liver. The stored version of glucose is often referred to as glycogen. When the body needs energy, for example, it will break down glycogen into glucose so that it can be used as fuel.
Muscle and liver glycogen stores are vital in providing energy during prolonged exercise, and strenuous activity can rapidly deplete these stores, leading to increased fatigue and a decline in performance. Liver glycogen, however, is particularly important because it controls blood glucose levels. This is important because the brain and other organs are constantly relying on the supply of glucose to function properly.
When sleeping, the body goes through a natural period of fasting. During this period, the liver gradually breaks down its glycogen stores to release glucose into the bloodstream. Because of this, following sleep, liver glycogen stores are automatically low (which is why having breakfast is important). There is research to suggest that eating a high-carbohydrate breakfast can prevent further declines in liver glycogen; however, it is not known if eating different types of carbohydrates within the breakfast (glucose and fructose together) will affect the liver's ability to store glycogen. This research will aid in understanding optimal ways to increase liver glycogen stores before performing exercise, which may influence exercise performance.
Therefore, the main aim of this study is:
1. Investigate whether a high fructose breakfast will increase liver glycogen storage
To achieve this, participants will be recruited to complete a randomised crossover study where they will undertake three different conditions. All laboratory trials will take place at the Manchester Metropolitan University Institute of Sport.
- No breakfast (Control)
- 3 g/kg of body mass of carbohydrate (of which contains 0% fructose)
- 3 g/kg of body mass of carbohydrate (of which contains50% fructose)
Liver glycogen stores will be measured using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). The investigators will measure liver glycogen content, liver volume, and stomach volume. Blood samples will also be taken to measure different metabolic hormone responses.
Study Overview
Status
Detailed Description
Glycogen stores in the muscle and liver play a crucial role in providing fuel during prolonged exercise and strenuous activities, which can rapidly deplete these stores, leading to increased fatigue and reduced performance. During prolonged exercise, liver glycogen is broken down to maintain blood glucose (sugar) levels and provide an important fuel source for the exercising muscles. Accordingly, liver glycogen is important for our ability to perform prolonged endurance exercise.
Following sleep, the body is placed under a natural period of fasting; because of this, the body's main source of fuel derives from liver glycogen stores, meaning hepatic glycogen stores decline sufficiently during this period. Accordingly, without sufficient pre-exercise carbohydrate intake, athletes begin training or competition with reduced liver glycogen availability, which can impair their ability to maintain blood glucose during prolonged exercise and may result in hypoglycaemia and subsequent fatigue. Whilst current guidelines suggest that pre-exercise carbohydrate intake may support the replenishment of depleted liver glycogen stores, it is currently unclear whether the composition of carbohydrates contained within the breakfast meal may impact the ability of the liver to store glycogen.
Fructose is primarily metabolised in the liver and enters hepatic carbohydrate metabolism downstream to key regulatory steps in glycolysis. Research has shown that fructose preferentially contributes to hepatic glycogen storage and, when co-ingested with glucose, enhances post-exercise hepatic glycogen synthesis when compared with glucose alone. Despite this, the effects of fructose within a high-carbohydrate breakfast following overnight fasting (where the metabolic and hormonal environment is markedly different) remain unknown.
As such, the present study aims to assess 1) the effect of a high-carbohydrate breakfast diet on liver glycogen storage and 2) the effect of fructose content on liver glycogen storage.
To achieve our aims, participants will complete three experimental conditions in a randomised, counterbalanced order: 1) no breakfast (control), 2) high carbohydrate breakfast (3 g/kg of body mass) (0% fructose), and 3) high carbohydrate breakfast (3 g/kg of body mass) (50% fructose). Hepatic glycogen concentrations will be quantified using non-invasive 13C magnetic resonance spectroscopy (MRS), with magnetic resonance imaging (MRI) used to assess liver volume and gastric volume. Secondary measures will include circulating metabolic and hormonal responses assessed via venous blood sampling. Primary and secondary outcomes will be compared across conditions to determine whether fructose co-ingestion alters hepatic glycogen storage relative to glucose intake and fasting. This study will provide mechanistic insight into the role of fructose in promoting hepatic glycogen synthesis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A male (at birth) aged between 18 and 45.
- Regularly training for a specific sport (must include cycling) at least 3 times per week (with the purpose of competing).
- VO2 peak >50 (ml.kg.min)
- A current non-smoker/vaper (must not have smoked or vaped within the last 6 months)
- Do not have any medical conditions or are taking any medications or supplements which can affect the study's outcome measures.
- Free from any metallic implants, including permanent jewellery (that can't be removed)
- No known intolerances or allergies to any component of the nutritional supplement
Exclusion Criteria:
- Are not a male (at birth) aged between 18 and 45.
- Do not regularly train for a specific sport (must include cycling) at least 3 times per week (with the purpose of competing).
- Does not have a VO2 max/peak >50 (ml.kg.min)
- A current smoker/vaper (must not have smoked or vaped within the last 6 months)
- Have any medical conditions or are taking any medications or supplements which can affect the study's outcome measures
- Have any metallic implants, including permanent jewellery (that can't be removed)
- Known intolerances or allergies to any component of the nutritional supplement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control
No breakfast
|
Participants will come in and receive no breakfast, which will act as a control group.
|
|
Experimental: 0% fructose
Breakfast containing 0% fructose
|
Participants will receive a breakfast of 3g/kg of body mass of carbohydrate with 0% fructose content.
|
|
Experimental: 50% fructose
Breakfast containing 50% fructose
|
Participants will receive a breakfast of 3g/kg of body mass of carbohydrate with 50% fructose content.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in liver glycogen content
Time Frame: 3 hours
|
The change in liver glycogen content will be determined using 13C magnetic resonance spectroscopy
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total carbohydrate oxidation
Time Frame: 3 hours
|
Total carbohydrate oxidation will be measured using indirect calorimetry
|
3 hours
|
|
Total fat oxidation
Time Frame: 3 hours
|
Total fat oxidation will be measured using indirect calorimetry
|
3 hours
|
|
Stomach volume
Time Frame: 3 hours
|
Stomach volume will be measured using MRI
|
3 hours
|
|
Plasma glucose
Time Frame: 3 hours
|
Measured via blood collection
|
3 hours
|
|
Plasma lactate
Time Frame: 3 hours
|
Measured via blood collection
|
3 hours
|
|
Plasma insulin
Time Frame: 3 hours
|
Measured via blood collection
|
3 hours
|
|
Plasma glucagon
Time Frame: 3 hours
|
Measured via blood collection
|
3 hours
|
|
Gastrointestinal symptoms
Time Frame: 3 hours
|
Participants will be asked to rate how they are feeling on a scale of 0-10 (0 = no discomfort and 10 = very severe discomfort) on whether they feel nauseous, having any regurgitation, stomach fullness, experiencing any cramps and if they have an urge to defecate.
|
3 hours
|
|
Appetite
Time Frame: 3 hours
|
To measure appetite (which will include being asked on hunger, fullness, satisfaction and prospective food consumption), participants will be shown a 100mm visual analog scale, which will have descriptors on both ends (e.g., I am not hungry at all, and I have never been hungrier in my life), and they will rate their appetite by drawing an intersecting vertical line along the horizontal line.
The previous rating will be hidden to prevent the influence of a prior rating on the subsequent reporting.
|
3 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 84304
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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