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

Zhejiang University

Status: Completed

Conditions: Healthy

Treatments: Behavioral: moderate-fat diet; Behavioral: low-fat diet; Behavioral: high-fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02355795

DUOLI201501

Details and patient eligibility

About

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.

Enrollment: 307 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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307 participants in 3 patient groups

low-fat diet

Experimental group

Description:

Participants will be provided low-fat diet for 6 months

Treatment:

Behavioral: low-fat diet

moderate-fat diet

Experimental group

Description:

Participants will be provided moderate-fat diet for 6 months

Treatment:

Behavioral: moderate-fat diet

high-fat diet

Experimental group

Description:

Participants will be provided high-fat diet for 6 months

Treatment:

Behavioral: high-fat diet