Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06684834

Intermittent Carbohydrate Restriction in Cardiometabolic Health

Led by University of Bath · Updated on 2024-11-12

36

Participants Needed

1

Research Sites

682 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intermittent Carbohydrate Restriction in Cardiometabolic Health

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Waist circumference of at least 94 cm (37 inches) if male or 80 cm (31.5 inches) if female, or BMI above 25 kg/m2
  • Fat mass index above 6 kg/m2 for males and above 9 kg/m2 for females
  • Aged between 18 and 65 years
  • Stable body weight with less than 3% change in the last three months
  • For females, tracking menstrual cycle regularity or oral contraceptive use
Not Eligible

You will not qualify if you...

  • Body weight of 120 kg or more
  • Plans to change diet or activity levels during the study
  • Current or past eating disorders
  • Major chronic diseases such as type 2 diabetes, heart disease, cancer, or chronic kidney disease
  • Use of medications affecting glucose or lipid levels
  • Currently pregnant, recently pregnant within 6 months, planning pregnancy, or breastfeeding
  • Donated more than 500 ml of blood in the last 3 months
  • Unable to understand or follow the study due to mental capacity or language barriers
  • Dietary restrictions to test meal ingredients like gluten or lactose
  • Irregular sleep patterns such as night-shift work
  • Any condition or behavior that poses personal risk or could bias the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Bath

Bath, Somerset, United Kingdom, BA2 7AY

Actively Recruiting

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Research Team

G

Guoda Karoblyte

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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