NCT06684834Completed
Intermittent Carbohydrate Restriction in Cardiometabolic Health
The Effects of Intermittent Carbohydrate Restriction on Metabolic Health and Energy Balance in Adults With Abdominal Overweight and Obesity
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
Metabolic conditions, such as heart disease, type 2 diabetes, and metabolic syndrome, are among the leading causes of disability and mortality worldwide. Identifying innovative lifestyle strategies to reduce metabolic risk remains a public health priority. Further research is essential to understand how low carbohydrate intake influences human metabolism and how intermittent carbohydrate restriction impacts weight loss and metabolic health markers. This study will investigate two interventions that restrict dietary carbohydrate intake on different schedules, examining their effects on metabolic health and energy balance in adults with abdominal overweight or obesity. The physiological mechanisms potentially underlying these effects will be explored by measuring a range of lifestyle and metabolic health parameters in both free-living and laboratory settings. A digital behaviour-change intervention will be incorporated after the dietary intervention to assess whether any metabolic effects can be sustained over time. The study employs a three-arm parallel-group design consisting of a two-week lifestyle monitoring phase, a four-week dietary intervention, and a four-week digital intervention, with four laboratory visits throughout each phase. During the dietary intervention, participants will be allocated to one of three groups: (i) carbohydrate restriction (\<8% of energy intake) on two consecutive days per week, (ii) carbohydrate restriction after 4 pm each day, or (iii) no dietary changes. Dietary intake, physical activity, and glucose levels will be monitored through wearable devices in free-living conditions. The digital intervention will use a mobile health application that provides individualised lifestyle recommendations and education based on data collected in free-living conditions. Laboratory-based measures will include anthropometry, body composition scans, indirect calorimetry, blood pressure monitoring, fat biopsies, and postprandial sampling of blood and expired air.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 24 Oct 2024
- Start date
- 5 Sept 2023
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- University of Bath
- Diseases
- Obesity
- NCT number
- NCT06684834
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 5 Sept 2023 to the primary completion date, 1 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous eating disorder
- Any condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment
Other illness
- Diagnosed with major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.)
Lab values
- Use of medication that may interfere with study outcomes (e.g. glucose or lipid lowering medications)
- Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit
Other
- Has a body weight of ≥120kg
- Plans to undertake other lifestyle modifications during the study to manage weight (e.g. changes in dietary intake or activity levels)
- Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating
- Insufficient mental capacity or language skills to independently understand and follow the study protocol
- Dietary restrictions to ingredients in test meals (e.g. gluten and lactose)
- Has an irregular sleeping pattern (e.g. due to undertaking night-shift work)
Who the study is looking for
- Waist circumference of ≥94 cm (37 inches) if male and ≥80 cm (31.5 inches) if female, or BMI above 25 kg/m2
- Fat mass index (FMI) of \>6 kg/m2 for males, and \>9 kg/m2 for females
- Aged between 18-65 years
- Has maintained a stable weight in the last three months (\<3% change in body mass)
- Keeps track of menstrual cycle regularity or oral contraceptive use (females only)
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Bath Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.