At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- 5:2 carbohydrate restriction (other), Early time-restricted carbohydrate intake (other)
- How long the study runs
- Study runs about 25 months (dates as stated)
- About the drug or intervention
- 5:2 carbohydrate restriction — other: Carbohydrate ingestion restricted to \<8% of energy intake on 2 self-selected consecutive days each week over 28-30 days. · Early time-restricted carbohydrate intake — other: Carbohydrate intake restricted to \<8% of energy intake after 4pm each day for 28 days.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 40
- Started
- 2023-09-05
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for obesity and overweight
- • NA - 40 participants
- • Metabolic conditions, such as heart disease, type 2 diabetes, and metabolic syndrome, are among the leading causes of disability and mortality worldwide
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with obesity and overweight
Where?
- • Bath - University of Bath
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
What 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)
Who cannot take part
- ✗Has a body weight of ≥120kg
- ✗Plans to undertake other lifestyle modifications during the study to manage weight (e.g. changes in dietary intake...
- ✗Current or previous eating disorder
- ✗Diagnosed with major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney...
- ✗Use of medication that may interfere with study outcomes (e.g. glucose or lipid lowering medications)
See the full criteria
Where Is This Study? (1 UK site)
University of Bath
Bath BA2 7AY, United Kingdom
Professor Julie Barnett (Associate Pro Vice-Chancellor, Research)
pro-vc-research@bath.ac.uk1225383162