Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial
NCT ID: NCT02355795
Last Updated: 2016-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
307 participants
INTERVENTIONAL
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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low-fat diet
Participants will be provided low-fat diet for 6 months
low-fat diet
Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively
moderate-fat diet
Participants will be provided moderate-fat diet for 6 months
moderate-fat diet
Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively
high-fat diet
Participants will be provided high-fat diet for 6 months
high-fat diet
Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively
Interventions
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low-fat diet
Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively
moderate-fat diet
Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively
high-fat diet
Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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National Basic Research Program, China
OTHER
National Natural Science Foundation of China
OTHER_GOV
Chinese PLA General Hospital
OTHER
Zhejiang University
OTHER
Responsible Party
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Duo li
Professor
Locations
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Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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Wan Y, Yuan J, Li J, Li H, Zhang J, Tang J, Ni Y, Huang T, Wang F, Zhao F, Li D. Unconjugated and secondary bile acid profiles in response to higher-fat, lower-carbohydrate diet and associated with related gut microbiota: A 6-month randomized controlled-feeding trial. Clin Nutr. 2020 Feb;39(2):395-404. doi: 10.1016/j.clnu.2019.02.037. Epub 2019 Feb 27.
Wan Y, Wang F, Yuan J, Li J, Jiang D, Zhang J, Li H, Wang R, Tang J, Huang T, Zheng J, Sinclair AJ, Mann J, Li D. Effects of dietary fat on gut microbiota and faecal metabolites, and their relationship with cardiometabolic risk factors: a 6-month randomised controlled-feeding trial. Gut. 2019 Aug;68(8):1417-1429. doi: 10.1136/gutjnl-2018-317609. Epub 2019 Feb 19.
Wan Y, Wang F, Yuan J, Li J, Jiang D, Zhang J, Huang T, Zheng J, Mann J, Li D. Effects of Macronutrient Distribution on Weight and Related Cardiometabolic Profile in Healthy Non-Obese Chinese: A 6-month, Randomized Controlled-Feeding Trial. EBioMedicine. 2017 Aug;22:200-207. doi: 10.1016/j.ebiom.2017.06.017. Epub 2017 Jun 20.
Other Identifiers
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DUOLI201501
Identifier Type: -
Identifier Source: org_study_id