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Completed

NCT Number: NCT02355795

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang University

Hangzhou, Zhejiang, 310058, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Fat Diet

Behavioral

Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively

moderate-fat diet

Behavioral

Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively

High-fat diet

Behavioral

Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Feb 4, 2015
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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