Executive Function Clinical Trial
Official title:
Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial
The purpose of this study is to estimate the effects of diet and exercise interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 28, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 24 Years |
Eligibility | Inclusion Criteria: - First and second year undergraduate students in Sun Yat-sen University. - BMI=22 kg/m^2. - Keeping weight stable for 3 months prior to study start (weight fluctuation <5kg). - Having the time and volunteering to receive the interventions. Exclusion Criteria: - Currently engaged in other weight-loss studies. - With high blood pressure, diabetes or other cardiovascular diseases. - With secondary obesity induced by medicine or other diseases. - 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 Yatsen 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 (12 weeks) | |
Secondary | Body fat percentage | Body fat percentage were measured by body composition analyzers. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Fat mass | Fat mass (in kg) were measured by body composition analyzers. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Systolic and diastolic blood pressure | Sitting systolic and diastolic blood pressure were measured with a validated electronic blood pressure monitor (model OMRON,HEM-7124). | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
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 (12 weeks) | |
Secondary | Fasting plasma glucose | Fasting plasma glucose were analyzed by the glucose oxidase method. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Fasting plasma insulin | Fasting plasma glucose were analyzed by the electrochemiluminescence method. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
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 (12 weeks) | |
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 (12 weeks) | |
Secondary | Change in appetite sensations | The appetite sensations were measured by the visual analogue scale (VAS).The VAS consisted of 100-mm lines and participants were required to place a vertical mark across the line corresponding best to their feelings of hunger, satisfaction, and fullness, with the scale ranging from 0 (not at all) to 100 (extremely). Quantification was performed by measuring the distance between the left end of the line and the vertical mark. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | High-Sensitivity C-Reactive Protein (hs-CRP) | The levels of the serum hs-CRP were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Intercellular adhesion molecule-1 (ICAM-1) | The levels of the serum ICAM-1 were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Tumor necrosis factor alpha (TNF-alpha) | The levels of the serum TNF-alpha were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Chemokine CCL2 | The levels of the serum chemokine CCL2 were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Vascular cell adhesion molecule (VCAM-1) | The levels of the serum VCAM-1 were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Interleukin-6 (IL-6) | The levels of the serum IL-6 were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Interleukin-8 (IL-8) | The levels of the IL-8 were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Leptin | The levels of the serum leptin were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Tau protein | The levels of the serum tau protein were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Brain-derived neurotrophic factor (BDNF) | The levels of the serum BDNF were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
Secondary | Vascular endothelial growth factor (VEGF) | The levels of the serum VEGF were analyzed using the Luminex Human Magnetic Assay kit. | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | |
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 (12 weeks) |
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