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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

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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: low-fat diet Behavioral: moderate-fat diet Behavioral: high-fat diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2014
Actual Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. adiponectin, leptin as measured by ELISA kits [ Time Frame: 0,1,2,3,4,5,and 6 months ]
    change from baseline will be reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355795


Locations
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China, Zhejiang
Zhejiang University
Hangzhou, Zhejiang, China, 310058
Sponsors and Collaborators
Zhejiang University
National Basic Research Program, China
National Natural Science Foundation of China
Chinese PLA General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duo li, Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT02355795     History of Changes
Other Study ID Numbers: DUOLI201501
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Keywords provided by Duo li, Zhejiang University:
weight change
diet
dietary fat
feeding design