- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250191
The Effects of 24-hour Fasting or Carbohydrate Restriction on Postprandial Metabolic Responses
The Acute Effects of Energy and Carbohydrate Restriction on Postprandial Metabolism
Most individuals spend the majority of the day in a fed state, making postprandial blood glucose and lipid regulation a central component of metabolic health. Short periods of fasting or reduced carbohydrate intake can occur frequently in daily life, whether through intentional dietary practices (e.g. intermittent fasting), cultural or religious traditions, or unstructured eating patterns. These periods can induce measurable metabolic changes, but the acute effects of a single 24-hour period of fasting or carbohydrate restriction on postprandial metabolism upon refeeding remain poorly characterised.
This study will examine how 24 hours of either complete fasting or low carbohydrate intake without energy restriction influence postprandial blood glucose and lipid concentrations, as well as related metabolic markers, in healthy adults, in comparison to a habitual high carbohydrate control diet. Participants will complete all three conditions in a randomised order, consuming a standardised meal test after each 24-hour condition. Repeated blood sampling and gas exchange measurements will be carried out to assess postprandial metabolic responses.
The aim of this study is to characterise whether acute periods of fasting and low carbohydrate restriction elicit distinct or comparable alterations in postprandial metabolic responses. A clearer understanding of these acute physiological effects can help inform how variations in eating patterns influence glucose and lipid handling in individuals without metabolic disease.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bath, United Kingdom, BA2 7AY
- University of Bath
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18-40 years
- Have a BMI of 18.5-29.9 kg/m2
Exclusion Criteria:
- Diagnosed with any major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.)
- Use of medication that may interfere with study outcomes (e.g. glucose or lipid-lowering medications)
- Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating
- Has a habitually low carbohydrate intake (<150g carbohydrates/day)
- Current or previous eating disorder
- Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit
- Insufficient mental capacity or language skills to independently understand and follow the study protocol
- Has an irregular sleeping pattern (e.g. due to undertaking night-shift work)
- Any other condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment
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 |
|---|---|
|
No Intervention: Habital control diet
100% of energy requirements, ≥150 carbohydrate/day
|
|
|
Experimental: Fasting
No energy intake
|
No food intake for 24 hours
|
|
Experimental: Carbohydrate Restriction
100% of energy requirements, ≤20g carbohydrate
|
Restriction of dietary carbohydrate to ≤5% of total energy intake for 24 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Triglyceride Concentration
Time Frame: After each 24-hour dietary condition
|
Plasma triglyceride concentrations assessed at baseline and postprandially for 2 hours after a mixed meal test
|
After each 24-hour dietary condition
|
|
Glucose Concentration
Time Frame: After each 24-hour dietary condition
|
Plasma glucose concentrations assessed at baseline and postprandially for 2 hours after a mixed meal test
|
After each 24-hour dietary condition
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin Concentration
Time Frame: After each 24-hour dietary condition
|
Plasma insulin concentrations assessed postprandially for 2 hours after a mixed meal test
|
After each 24-hour dietary condition
|
|
Non-esterified Fatty Acid Concentration
Time Frame: After each 24-hour dietary condition
|
Plasma non-esterified fatty acid concentrations assessed at baseline and postprandially for 2 hours after a mixed meal test
|
After each 24-hour dietary condition
|
|
Beta-hydroxybutyrate Concentration
Time Frame: After each 24-hour dietary condition
|
Plasma beta-hydroxybutyrate concentrations assessed at baseline and postprandially for 2 hours after a mixed meal test
|
After each 24-hour dietary condition
|
|
Substrate Oxidation
Time Frame: After each 24-hour dietary condition
|
Lipid and carbohydrate oxidation assessed via indirect calorimetry at baseline and during 2-hour mixed meal test
|
After each 24-hour dietary condition
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 0590
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Glucose and Lipid Metabolism
-
Maastricht University Medical CenterRecruitingGlucose Metabolism | Lipid MetabolismNetherlands
-
University of JenaCompletedGlucose Metabolism | Lipid Metabolism | SatietyGermany
-
Göteborg UniversityÖrebro University, SwedenCompletedBlood Glucose | Lipid Metabolism | Oral Glucose Tolerance Test | Carbohydrate MetabolismSweden
-
Wageningen University and ResearchCompletedGlucose Metabolism | Lipid MetabolismNetherlands
-
Olga Ramich (formerly Pivovarova)Charite University, Berlin, GermanyNot yet recruitingChronodisruption | Glucose and Lipid Metabolism | Shift Work DisorderGermany
-
Heart Health Research CenterAstraZenecaCompletedMetabolism Disorder, Glucose | Metabolism Disorder, LipidChina
-
Xijing HospitalCompletedVitiligo | Metabolism Disorder, Glucose | Metabolism Disorder, LipidChina
-
Tufts UniversityCompletedDyslipidemia | Impaired Glucose Tolerance
-
Purdue UniversityAlmond Board of CaliforniaCompletedGlucose Intolerance | Appetite Disorders | Lipid Metabolism Disorder | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
Solvay PharmaceuticalsCompletedDyslipidemia/Glucose Metabolism DisorderPoland, Ukraine, United Kingdom
Clinical Trials on Fasting
-
Kasr El Aini HospitalCompleted
-
Charite University, Berlin, GermanyKarl and Veronica Carstens FoundationTerminatedFertility Issues | Fertility Disorders | IVF | Sub Fertility, Female | Sub-fertilityGermany
-
Charite University, Berlin, GermanyCompletedCancer | Fasting | NeoplasiaGermany
-
Cairo UniversityWithdrawnPolycystic Ovary Syndrome | InfertilityEgypt
-
Shiraz University of Medical SciencesCompletedCoronary Artery DiseaseIran, Islamic Republic of
-
University of British ColumbiaRecruitingGlucose Tolerance | Fasting | Immune FunctionCanada
-
HealthPartners InstituteCompletedDiabetes Mellitus | Hyperlipidemia | Normal Glucose MetabolismUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNot yet recruitingPancreatitis | Pancreatitis, Chronic | Pancreatitis, Acute | Pancreas Disease | Acute Recurrent PancreatitisUnited States
-
Universidade de Passo FundoFederal University of Rio Grande do SulCompleted