The Effect of Dietary Carbohydrate Manipulation on All Major Aspects of Energy Balance: A 12-week Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Physical Activity Energy Expenditure (kJ/Day or kcal/Day)
研究概览
简要总结
This study will investigate how dietary sugar and carbohydrates influence metabolism and health across a 12-week period, with a focus on physical activity. One third of participants will eat a diet with typical amounts of sugar and carbohydrate, one third of participants will eat a diet with sugar intake restricted, and the final third of participants will eat a diet where both sugar and total carbohydrates are restricted and replaced with fat.
详细描述
Sugar is perceived negatively, leading to government taxation and targets to reduce consumption. These actions have been taken based on the limited evidence that high-sugar diets are associated with greater total energy intake. However, energy intake is only one half of the energy balance equation (energy in vs energy out). Without considering energy expenditure, it is impossible to fully understand the effects of sugar on health. Removing dietary sugar or carbohydrates from the diet may influence energy balance through mechanisms other than energy intake - for example by reducing levels of physical activity.
Understanding dietary regulators of energy balance is more important than ever because diseases like obesity are a consequence of energy surplus (i.e. energy in > energy out). No studies have investigated a causal role of dietary sugar or carbohydrate on energy balance. The proposed research will seek to understand the responses to manipulating dietary carbohydrate and sugar content on energy balance and health. This research will enable the public to make informed dietary choices about carbohydrate and sugar consumption.
To achieve this, healthy non-obese adults, aged 18-65 years will be recruited to take part in an intervention study with measures of energy intake, energy expenditure, metabolic health, gut microbiota, and appetite. All laboratory trials will take place at the University of Bath. Participants will be randomised to consume one of three diets for a period of 12 weeks, with laboratory visits at baseline, at week 4, and at week 12:
- CONTROL (moderate sugar) - reflecting the composition of a typical European diet
- Low sugar - the same composition of a typical European diet but with <5% energy intake from sugar
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar, replacing carbohydrate energy with fat
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
- •Body mass index 18.5-29.9 kg∙m-2
- •Age 18-65 years
- •Able and willing to provide informed consent and safely comply with study procedures
- •Females to maintain record of regular menstrual cycle phase/contraceptive use
- •No anticipated changes in physical activity during the first 4 weeks of the study (e.g. holidays or training programmes)
排除标准
- •Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- •Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- •Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- •Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- •Any reported recent (<6 months) change in body mass (± 3%)
- •Use of antibiotic medication in the last 3 months
- •Use of prebiotic or probiotic products in the last month
结局指标
主要结局
Physical Activity Energy Expenditure (kJ/Day or kcal/Day)
时间窗: 7 days (across 12 weeks) - Primary outcome at week 4
24-hour physical activity energy expenditure (kJ/day or kcal/day)
次要结局
- Body Mass(12 weeks)
- Bone Mineral Content(12 weeks)
- Energy Intake and Dietary Macronutrient Composition(12 weeks)
- Energy Expended in Different Physical Activity Intensities (MET Categories) (kJ or kcal)(7 days (across 12 weeks))
- Substrate Oxidation(12 weeks)
- Blood Pressure(12 weeks)
- Bone Mineral Density(12 weeks)
- Time Spent in Different Physical Activity Intensities (MET Categories) (Minutes)(7 days (across 12 weeks))
- Android Fat Mass(12 weeks)
- Resting Metabolic Rate(12 weeks)
- Subjective Appetite and Mood Ratings(12 weeks)
- Fat Mass(12 weeks)
- Fat-free Mass(12 weeks)
- Step Count(12 weeks)
- Muscle Glycogen Concentrations(12 weeks)
- Gynoid Fat Mass(12 weeks)
- Food Preference Ratings(12 weeks)
- Adipose Tissue Gene Expression(12 weeks)
- Muscle Tissue Gene Expression(12 weeks)
- Waist and Hip Circumference(12 weeks)
- Fasting Metabolite/Hormone Profile(12 weeks)
- Postprandial Metabolite/Hormone Profile(4 hours (across 12 weeks))
- Interstitial Glucose Concentrations(14 days (across 12 weeks))
- Adipose Tissue Protein Expression(12 weeks)
- Muscle Tissue Protein Expression(12 weeks)
- Gut Microbiome Characterisation(12 weeks)
- Urinary Acetoacetate Concentrations(12 weeks)
- Urine Urea Nitrogen Excretion(12 weeks)