Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02355795 |
Recruitment Status :
Completed
First Posted : February 4, 2015
Last Update Posted : November 28, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Behavioral: low-fat diet Behavioral: moderate-fat diet Behavioral: high-fat diet | Not Applicable |
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 |
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 |
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
China, Zhejiang | |
Zhejiang University | |
Hangzhou, Zhejiang, China, 310058 |
Responsible Party: | Duo li, Professor, Zhejiang University |
ClinicalTrials.gov Identifier: | NCT02355795 |
Other Study ID Numbers: |
DUOLI201501 |
First Posted: | February 4, 2015 Key Record Dates |
Last Update Posted: | November 28, 2016 |
Last Verified: | November 2016 |
weight change diet dietary fat feeding design |