Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial
1 other identifier
interventional
307
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 25, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedNovember 28, 2016
November 1, 2016
11 months
January 25, 2015
November 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body weight in kilograms as measured by a calibrated scale
change from baseline will be reported
0,1,2,3,4,5,and 6 months
Secondary Outcomes (5)
waist circumference as measured by an anthropometric measuring tape
0,1,2,3,4,5,and 6 months
blood pressure as measured by a validated automated sphygmomanometer
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
fasting glucose, insulin, glycated serum protein as measured by an immunology 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
Study Arms (3)
low-fat diet
EXPERIMENTALParticipants will be provided low-fat diet for 6 months
moderate-fat diet
EXPERIMENTALParticipants will be provided moderate-fat diet for 6 months
high-fat diet
EXPERIMENTALParticipants will be provided high-fat diet for 6 months
Interventions
Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively
Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively
Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively
Eligibility Criteria
You may qualify if:
- Students in Zhejiang University or working stuff in the Chinese PLA General Hospital
- ≤ 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Universitylead
- National Basic Research Program, Chinacollaborator
- National Natural Science Foundation of Chinacollaborator
- Chinese PLA General Hospitalcollaborator
Study Sites (1)
Zhejiang University
Hangzhou, Zhejiang, 310058, China
Related Publications (3)
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.
PMID: 30876827DERIVEDWan 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.
PMID: 30782617DERIVEDWan 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.
PMID: 28655596DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 25, 2015
First Posted
February 4, 2015
Study Start
November 1, 2014
Primary Completion
October 1, 2015
Last Updated
November 28, 2016
Record last verified: 2016-11