Study on the Phenotype and Gut Microbiome Composition of Healthy Superlean Individuals (BMI < 18.5)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Glucose
研究概览
简要总结
The goal of this observational study is to build on our previous work to further characterise the phenotype of superlean individuals (BMI < 18.5) when compared to normal BMI people (BMI 21.5 to 25). This will include characterising the body composition, food intake behaviour, circulating hormone levels, genetics and characteristics of the gut microbiota. The investigators expect to recruit up to 200 healthy superlean and control volunteers respectively,
详细描述
The focus of this work is to characterise the phenotype and genotype of individuals who have low BMI ( < 18.5) but are otherwise healthy and do not have eating disorders. The investigators term this group 'superlean' individuals. The study is observational and the investigators aim to establish a healthy superlean cohort,and use the combined metagenomic and metabolomic multi-omics analysis techniques, combined with imaging and physiological measurements, to focus on the correlation between gut microbiota characteristics and metabolism in superlean population. The investigators expect to recruit up to 200 healthy superlean and control volunteers (BMI 21.5 to 25) respectively, to explore the microbiota characteristics and differences between control and healthy superlean populations by measuring the basic physical indicators and metabolic parameters. This will include analyzing the postprandial hormonal changes, appetite differences, and changes in the gut microbiome and serum metabolome in the two groups of volunteers, establishing the relationship between the gut microbiota and the metabolite and metabolic phenotypes of the body, and exploring the gut microbiota.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control group (21.5≤ BMI<25), Superlean group (BMI≤18.5)
- •Age between 25-40 years old
排除标准
- •Having metabolic diseases or eating disorders
- •Recent weight loss due to various disease causes
- •Being treated for weight loss
- •Having an infectious disease
- •Pregnant and lactating women
- •People with blood sickness, pathological hypo- or hypertension
- •People suffering from claustrophobia
- •No metal implants in the body
- •Use of antibiotics, probiotics, oral laxatives, etc. within 8 weeks
结局指标
主要结局
Glucose
时间窗: Through study completion, an average of 2 years, will be recorded for a consecutive of 7 days.
Fasting and post-prandial glucose after a standard meal will be recorded by the continuous glucose monitoring system.
Body temperature
时间窗: Through study completion, an average of 2 years, will be measured before and after feeding.
Body temperature will be measured before and after feeding using a thermal imaging camera.
Body shape
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Body shape will be measured using a whole body laser scanner.
Energy intake
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Response on standard feeding table, the food consumption will be recorded continuously by balances underneath each food dish. The total energy intake will be calculated in KJ (kilojoule).
Microbiome
时间窗: Through study completion, an average of 2 years, will be measured after samples collected.
Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.
Genetics
时间窗: Through study completion, an average of 2 years, will be measured after samples collected.
Polymorphic variation will be assessed in a panel of SNPs (single nucleotide polymorphism) previously linked to body composition and physical activity using a Mass array sequencer.
Fat free mass
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).
Circulating hormones
时间窗: Through study completion, an average of 2 years, will be measured after standard intervention meal.
Levels of circulating hormones (including leptin, insulin, ghrelin etc) will be measured when fasted and after a standard intervention meal. Levels of circulating hormones in the serum will be measured by ELISA (Bio Tek, Synergy4) in mmol/L.
Weight
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Volunteers will be asked to fast for 10 hours and measured fasting weight.
Hip circumferences
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Hip circumferences will be measured using a whole body laser scanner.
Fat mass
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
Blood pressure
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.
Resting energy expenditure
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
The measurement of resting energy expenditure will be performed using indirect calorimetry.
Metabolites
时间窗: Through study completion, an average of 2 years, will be measured after samples collected.
Abundance of metabolites will be from metabolomic profiling of serum and feces by LC-MS (liquid chromatography-mass spectrometry).
Height
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Height will be measured by seca 217 stable stadiometer.
Waist circumferences
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Waist circumferences will be measured using a whole body laser scanner.
Bone mineral density
时间窗: Through study completion, an average of 2 years, will be measured on arrival.
Bone mineral density will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
Physical activity
时间窗: Through study completion, an average of 2 years, will be recorded for a consecutive of 7 days.
Physical activity of the participants will be recorded using GT3X monitor for a consecutive of 7 days.
次要结局
未报告次要终点
研究者
John R. Speakman
Professor
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences