Weight Loss Clinical Trial
Official title:
Effects of Caloric Restriction and Exercise on Body Weight, Cardiometabolic Risk Markers, Immune Function, and Intestinal Flora in College Students: a Randomized Controlled Trial
Verified date | September 2021 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to estimate the effects of caloric restriction and exercise on body weight, cardiovascular metabolic markers, immune function, and intestinal flora among college students, as well as the underlying mechanisms.
Status | Completed |
Enrollment | 195 |
Est. completion date | April 12, 2020 |
Est. primary completion date | April 5, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 24 Years |
Eligibility | Inclusion Criteria: 1. First and second year undergraduate students in Sun Yat-sen University. 2. BMI=22 kg/m2. 3. Having the time and volunteering to receive the interventions. Exclusion Criteria: 1. Currently engaged in other weight-lossing studies. 2. With secondary obesity induced by medicine or other diseases. 3. With high blood pressure, diabetes or other cadiovascular diseases. 4. Contraindication to exercise. |
Country | Name | City | State |
---|---|---|---|
China | Department of Maternal and Child Health and Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body weight | Body weight change of participants | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention | |
Secondary | Body composition | Skeletal muscle mass and fat mass were measured by body composition analyzers. | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention | |
Secondary | Serum lipid levels | Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method. | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention | |
Secondary | Fasting plasma glucose | Fasting plasma glucose were analyzed by the glucose oxidase method. | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention | |
Secondary | Systolic and diastolic blood pressure | Sitting systolic and diastolic blood pressure were measured with a validated mercury sphygmomanometer (model XJ1ID, China) and TZ-1 stethoscope. | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention | |
Secondary | Immune inflammation indicators | Immune and inflammatory indicators (ICAM-1, CCL2, VCAM-1, IL-6, IL-8, TNF-alpha, Leptin, Tau, BDNF, VEGF) were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention | |
Secondary | Intestinal flora | To measure the change of intestinal flora by analyzing feces genome 16S rDNA | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention | |
Secondary | Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A) | The executive functions were measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report Form. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention | |
Secondary | Circulating metabolome | To measure the change of circulating metabolome by LC-MS/MS method. | Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention |
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