NCT02355795已完成不适用
Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial
Zhejiang University1 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2014年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 307
- 试验地点
- 1
- 主要终点
- body weight in kilograms as measured by a calibrated scale
研究概览
简要总结
The aim of the current study is to evaluate the effects of diets with three levels of dietary fat on weight change and related cardiometabolic risk factors in a 6-month randomized controlled-feeding trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students in Zhejiang University or working stuff in the Chinese PLA General Hospital
- •18 ≤ age ≤ 35
- •Body Mass Index < 28*
- •Are willing to eat all of the study foods even when full
- •Are willing to eat only foods provided
- •Are willing to avoid strenuous activity during the 6-mo intervention
排除标准
- •Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
- •Total cholesterol ≥ 239 mg/dL
- •Low-density lipoprotein cholesterol ≥ 159 mg/dL
- •Triglycerides ≥ 199 mg/dL
- •Blood glucose ≥ 110 mg/dL
- •Change in body weight exceeding ± 10% during the prior year
- •Energy intake is too low or too high
- •Unwillingness or special requirement for diet that could not be modified
- •Poor adherence during the recruiting meeting or unsatisfactory completion of keeping food diary or filling questionnaire at any time before randomization
- •Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
- •Have a history of diagnosed CVD, diabetes, cancer or inflammatory diseases
- •Have a history of a mental illness
- •Have diagnosed endocrine, pulmonary or hematological disease
- •Have diagnosed bowel disease or malabsorption that would prevent the participants from complying with the dietary restrictions of the feeding trial
- •Renal or liver insufficiency
- •Other chronic disease thought to interfere with the effect of the diet or with participation or adherence
- •Current use of supplements or anti-inflammation medications or medications affecting glucose, lipid metabolism and blood pressure
- •Smoking or alcoholic beverage intake >1 times per week
- •Current or planned pregnancy prior to end of study, or breast-feeding
- •Irregular menstrual cycles
- •Have birth control medication
结局指标
主要结局
body weight in kilograms as measured by a calibrated scale
时间窗: 0,1,2,3,4,5,and 6 months
change from baseline will be reported
次要结局
- blood pressure as measured by a validated automated sphygmomanometer(0,1,2,3,4,5,and 6 months)
- waist circumference as measured by an anthropometric measuring tape(0,1,2,3,4,5,and 6 months)
- fasting blood lipids as measured by a clinical chemistry analyzer(0,1,2,3,4,5,and 6 months)
- adiponectin, leptin as measured by ELISA kits(0,1,2,3,4,5,and 6 months)
- fasting glucose, insulin, glycated serum protein as measured by an immunology analyzer(0,1,2,3,4,5,and 6 months)
研究者
Duo li
Professor
Zhejiang University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Pilot study on the effect of different dietary fatty acids on impaired glucose tolerance in obese urban Gambian womeISRCTN24376821Medical Research Council (MRC) (UK)61
已完成
不适用
Exploring the Effects of Varying Fat:Carbohydrate Diet Permutations on Gastric Emptying and Metabolic Status Using Human Postprandial ModelPostprandial LipemiaPostprandial GlycemiaGastric EmptyingNCT05977244Malaysia Palm Oil Board12
进行中（未招募）
不适用
Deciphering the Role of Dietary Fatty Acids on Extracellular Vesicles-mediated Intercellular CommunicationObesityMetabolic SyndromeMetabolic DisorderInflammationImmune System and Related DisordersNCT06051461University of Seville40
已完成
不适用
Controlled Feeding ExperimentEffect of Diet on Microbiome CompositionNCT00951756James Lewis10
已完成
2 期
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate FormulationMale HypogonadismNCT00924612Clarus Therapeutics, Inc.16