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RECRUITING
NCT06684834
NA

Intermittent Carbohydrate Restriction in Cardiometabolic Health

Sponsor: University of Bath

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-09-05

Completion Date

2036-10

Last Updated

2024-11-12

Healthy Volunteers

Yes

Interventions

OTHER

5:2 carbohydrate restriction

Carbohydrate ingestion restricted to \<8% of energy intake on 2 self-selected consecutive days each week over 28-30 days. Ad libitum dietary amount, type and pattern followed on the remaining 5 days each week.

OTHER

Early time-restricted carbohydrate intake

Carbohydrate intake restricted to \<8% of energy intake after 4pm each day for 28 days. Ad libitum dietary amount, type and pattern followed before 4pm.

Locations (1)

University of Bath

Bath, Somerset, United Kingdom