Application of New Technologies and Tools to Nutrition Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
研究概览
简要总结
The overall objective of the research is to develop new methods for studying the link between diet, health and disease.
详细描述
The enquiry consists of two part. A metabolomic biomarker discovery study followed by a randomised controlled trial of moderate dietary induced weight loss.
A cohort of moderately overweight men and women will undergo a metabolomic study follow by randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week period. This intervention will improve the volunteer's body composition and reduce their risk of developing diabetes.
Extensive tests will be conducted before and after the dietary intervention using emerging technologies with current state-of-the-art methods. These tests will monitor the numerous physiological adaptations that have occurred on a gene, cell, organ and organismic level.
The study will, therefore, aim for a scientific breakthrough by developing a series of novel biological "markers" that can accurately determine an individual's health status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)
- •Age between 50-65 years
排除标准
- •Weight change of ≥ 3kg in the preceding 3 months
- •Current smokers
- •Substance abuse
- •Excess alcohol intake
- •Pregnancy
- •Cardiovascular disease
- •Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- •Kidney disease
- •Liver disease
- •Pancreatitis
- •Have any metallic or magnetic implants such as pacemakers
- •Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
研究组 & 干预措施
Life style advice
reduce energy intake by 20% less than estimated energy expenditure.
干预措施: Metabolomic and Energy Intake Restriction (Behavioral)
UK background diet
Diet where energy intake will be matched with estimated energy expenditure.
干预措施: Metabolomic and Energy Intake Restriction (Behavioral)
Metabolomic inquiry
This inquiry took place prior to the randomized controlled trial and include 50 volunteers who will then be asked to volunteers of the weight loss study. Were randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
干预措施: Metabolomic and Energy Intake Restriction (Behavioral)
结局指标
主要结局
Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
时间窗: Baseline, 12 weeks
Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the "Diet" Arm/Group.
Insulin Sensitivity
时间窗: Baseline, 12 weeks
Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the "Exercise" and "Exercise, Control" groups. No data were collected for this Outcome from the remaining groups.
次要结局
- Genome Integrity (DNA Methylation and Telomere Length)(12 weeks)
- Body Composition(Baseline, 12 weeks)
- Body Weight(Baseline, 12 weeks)
- Changes in Adipocyte Morphology(12 weeks)