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

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ClinicalTrials.gov Identifier: NCT02355795
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : November 28, 2016
Sponsor:
Collaborators:
National Basic Research Program, China
National Natural Science Foundation of China
Chinese PLA General Hospital
Information provided by (Responsible Party):
Duo li, Zhejiang University

Tracking Information
First Submitted Date  ICMJE January 25, 2015
First Posted Date  ICMJE February 4, 2015
Last Update Posted Date November 28, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Change in waist circumference [ Time Frame: 0,30,60,90,120,150,and 180days ]
    change in waist circumference
  • Change in blood pressure [ Time Frame: 0,30,60,90,120,150,and 180days ]
    change in blood pressure
  • Change in fasting glucose level [ Time Frame: 0,30,60,90,120,150,and 180days ]
    change in in fasting glucose level
  • Change in fasting serum triglyceride level [ Time Frame: 0,30,60,90,120,150,and 180days ]
    change in fasting serum triglyceride level
  • Change in fasting high density lipoprotein cholesterol level [ Time Frame: 0,30,60,90,120,150,and 180days ]
    change in fasting high density lipoprotein cholesterol level
Change History Complete list of historical versions of study NCT02355795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2016)
  • 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
  • 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
  • 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
  • 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
  • adiponectin, leptin as measured by ELISA kits [ Time Frame: 0,1,2,3,4,5,and 6 months ]
    change from baseline will be reported
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Change in serum fatty acids [ Time Frame: 0,90,and 180 days ]
    change in serum fatty acids
  • Change in body composition [ Time Frame: 0,30,60,90,120,150,and 180 days ]
    change in body weight and body fat percentage
  • Change in insulin sensitity [ Time Frame: 0,30,60,90,120,150,and 180 days ]
    change in insulin sensitity
  • Change in intestinal flora [ Time Frame: 0,30,60,90,120,150,and 180 days ]
    change in intestinal flora
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Behavioral: low-fat diet
    Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively
  • Behavioral: moderate-fat diet
    Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively
  • Behavioral: high-fat diet
    Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively
Study Arms  ICMJE
  • Experimental: low-fat diet
    Participants will be provided low-fat diet for 6 months
    Intervention: Behavioral: low-fat diet
  • Experimental: moderate-fat diet
    Participants will be provided moderate-fat diet for 6 months
    Intervention: Behavioral: moderate-fat diet
  • Experimental: high-fat diet
    Participants will be provided high-fat diet for 6 months
    Intervention: Behavioral: high-fat diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2016)
307
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2015)
300
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02355795
Other Study ID Numbers  ICMJE DUOLI201501
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duo li, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE
  • National Basic Research Program, China
  • National Natural Science Foundation of China
  • Chinese PLA General Hospital
Investigators  ICMJE Not Provided
PRS Account Zhejiang University
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP