The Effects of Intermittent Carbohydrate Restriction on Metabolic Health and Energy Balance in Adults with Abdominal Overweight and Obesity

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
United Kingdom
University of Bath
RECRUITING
Bath
Contact Information
Primary
Guoda Karoblyte
gk678@bath.ac.uk
+44 (0) 1225 386478
Time Frame
Start Date: 2023-09-05
Estimated Completion Date: 2036-10
Participants
Target number of participants: 36
Treatments
Experimental: 5:2 carbohydrate restriction (5:2CR)
Laboratory measurements will be obtained before and after the intervention. Physical activity, dietary intake and interstitial glucose concentrations will be monitored in free-living conditions throughout the intervention.
Experimental: Early time-restricted carbohydrate intake (eTRC)
Laboratory measurements will be obtained before and after the intervention. Physical activity, dietary intake and interstitial glucose concentrations will be monitored in free-living conditions throughout the intervention.
No_intervention: Lifestyle maintenance (control)
Laboratory measurements will be obtained before and after the intervention. Physical activity, dietary intake and interstitial glucose concentrations will be monitored in free-living conditions throughout the intervention.
Sponsors
Leads: University of Bath

This content was sourced from clinicaltrials.gov