Healthy
Conditions
Keywords
weight change, diet, dietary fat, feeding design
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.
Interventions
BEHAVIORALlow-fat diet
Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively
BEHAVIORALmoderate-fat diet
Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively
BEHAVIORALhigh-fat diet
Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively
Sponsors
National Basic Research Program, China
National Natural Science Foundation of China
Chinese PLA General Hospital
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body weight in kilograms as measured by a calibrated scale | 0,1,2,3,4,5,and 6 months | change from baseline will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| waist circumference as measured by an anthropometric measuring tape | 0,1,2,3,4,5,and 6 months | change from baseline will be reported |
| blood pressure as measured by a validated automated sphygmomanometer | 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 | 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 | 0,1,2,3,4,5,and 6 months | change from baseline will be reported |
| adiponectin, leptin as measured by ELISA kits | 0,1,2,3,4,5,and 6 months | change from baseline will be reported |
Countries
China
Outcome results
None listed