The Effects of Intermittent Carbohydrate Restriction on Metabolic Health and Energy Balance in Adults With Abdominal Overweight and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post Prandial Triglyceride Area Under the Curve (AUC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
- •Current or previous eating disorder
- •Diagnosed with major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.)
- •Use of medication that may interfere with study outcomes (e.g. glucose or lipid lowering medications)
- •Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating
- •Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit
- •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)
- •Any condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment
研究组 & 干预措施
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.
干预措施: 5:2 carbohydrate restriction (Other)
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.
干预措施: Early time-restricted carbohydrate intake (Other)
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.
结局指标
主要结局
Post Prandial Triglyceride Area Under the Curve (AUC)
时间窗: Pre and post intervention (4 weeks)
Plasma triglyceride concentrations assessed postprandially for 5 hours after a mixed meal test
次要结局
- Fat Mass(Pre and post intervention (4 weeks))
- Lean Body Mass(Pre and post intervention (4 weeks))
- Fasting and Post Prandial Glucose Concentration(Pre and post intervention (4 weeks))
- Fasting and Post Prandial Insulin Concentration(Pre and post intervention (4 weeks))
- Fasting and Post Prandial NEFA Concentration(Pre and post intervention (4 weeks))
- Fasting Triglyceride Concentration(Pre and post intervention (4 weeks))
- Fasting Total Cholesterol Concentration(Pre and post intervention (4 weeks))
- Fasting LDL-C Concentration(Pre and post intervention (4 weeks))
- Fasting HDL-C Concentration(Pre and post intervention (4 weeks))
- Substrate Oxidation(Pre and post intervention (4 weeks))
- Adipose Tissue Gene Expression(Pre and post intervention (4 weeks))
- Adipose Tissue Protein Expression(Pre and post intervention (4 weeks))
研究者
Guoda Karoblyte
Principal Investigator
University of Bath