Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial

November 24, 2016 updated by: Duo li, Zhejiang University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310058
        • Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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 Exclusion criteria：
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low-fat diet
Participants will be provided low-fat diet for 6 months
Behavioral: low-fat diet
Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively
Experimental: moderate-fat diet
Participants will be provided moderate-fat diet for 6 months
Behavioral: moderate-fat diet
Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively
Experimental: high-fat diet
Participants will be provided high-fat diet for 6 months
Behavioral: high-fat diet
Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight in kilograms as measured by a calibrated scale
Time Frame: 0,1,2,3,4,5,and 6 months
change from baseline will be reported
0,1,2,3,4,5,and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
waist circumference as measured by an anthropometric measuring tape
Time Frame: 0,1,2,3,4,5,and 6 months
change from baseline will be reported
0,1,2,3,4,5,and 6 months
blood pressure as measured by a validated automated sphygmomanometer
Time Frame: 0,1,2,3,4,5,and 6 months
change from baseline will be reported
0,1,2,3,4,5,and 6 months
fasting blood lipids as measured by a clinical chemistry analyzer
Time Frame: 0,1,2,3,4,5,and 6 months
change from baseline will be reported
0,1,2,3,4,5,and 6 months
fasting glucose, insulin, glycated serum protein as measured by an immunology analyzer
Time Frame: 0,1,2,3,4,5,and 6 months
change from baseline will be reported
0,1,2,3,4,5,and 6 months
adiponectin, leptin as measured by ELISA kits
Time Frame: 0,1,2,3,4,5,and 6 months
change from baseline will be reported
0,1,2,3,4,5,and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

National Natural Science Foundation of China
Chinese PLA General Hospital
National Basic Research Program, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 25, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 24, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DUOLI201501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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