Effects of intermittent carbohydrate restriction on metabolic health
The Effects of Intermittent Carbohydrate Restriction on Metabolic Health and Energy Balance in Adults with Abdominal Overweight and Obesity
This study is testing if two different ways of cutting back on carbs can improve metabolic health and energy levels in adults who are overweight or obese.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Bath Academic / other |
| Locations | 1 site (Bath, Somerset) |
| Trial ID | NCT06684834 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of two different carbohydrate restriction schedules on metabolic health and energy balance in adults with abdominal overweight or obesity. Participants will follow either a 5:2 carbohydrate restriction or an early time-restricted carbohydrate intake approach. The study aims to measure various lifestyle and metabolic health parameters in both free-living and controlled laboratory settings. Additionally, a digital behavior-change intervention will be implemented post-diet to evaluate any lasting metabolic effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with abdominal overweight or obesity, indicated by specific waist circumference or BMI criteria.
Not a fit: Patients with major chronic conditions such as type 2 diabetes or coronary heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide innovative dietary strategies to improve metabolic health and aid in weight management for individuals with obesity.
How similar studies have performed: Other studies have shown promising results with carbohydrate restriction approaches, suggesting potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Waist circumference of ≥94 cm (37 inches) if male and ≥80 cm (31.5 inches) if female, or BMI above 25 kg/m2 2. Fat mass index (FMI) of \>6 kg/m2 for males, and \>9 kg/m2 for females 3. Aged between 18-65 years 4. Has maintained a stable weight in the last three months (\<3% change in body mass) 5. Keeps track of menstrual cycle regularity or oral contraceptive use (females only) Exclusion Criteria: 1. Has a body weight of ≥120kg 2. Plans to undertake other lifestyle modifications during the study to manage weight (e.g. changes in dietary intake or activity levels) 3. Current or previous eating disorder 4. Diagnosed with major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.) 5. Use of medication that may interfere with study outcomes (e.g. glucose or lipid lowering medications) 6. Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating 7. Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit 8. Insufficient mental capacity or language skills to independently understand and follow the study protocol 9. Dietary restrictions to ingredients in test meals (e.g. gluten and lactose) 10. Has an irregular sleeping pattern (e.g. due to undertaking night-shift work) 11. Any condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment
Where this trial is running
Bath, Somerset
- University of Bath — Bath, Somerset, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Guoda Karoblyte
- Email: gk678@bath.ac.uk
- Phone: +44 (0) 1225 386478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.