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

Study Overview
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Brief Summary
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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.

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: low-fat diet
* Behavioral: moderate-fat diet
* Behavioral: high-fat diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference as measured by an anthropometric measuring tape | change from baseline will be reported | 0,1,2,3,4,5,and 6 months | 
| blood pressure as measured by a validated automated sphygmomanometer | 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 | 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 | change from baseline will be reported | 0,1,2,3,4,5,and 6 months | 
| adiponectin, leptin as measured by ELISA kits | change from baseline will be reported | 0,1,2,3,4,5,and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight change, diet, dietary fat, feeding design