Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora
- Conditions
- Cardiometabolic RiskWeight LossImmune SystemIntestinal Microbiome
- Interventions
- Behavioral: ExerciseBehavioral: Caloric restriction
- Registration Number
- NCT04275440
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
In recent decades, carbohydrate-centered food pattern has brought worrying negative effects on human health, including increasing incidence of overweight, obesity, and cardiovascular diseases. Animal experiments based on rhesus monkey showed that caloric restriction could prolong their healthy life years, while reports from population-based studies are quite inconclusive. There are some studies reporting that caloric restriction did reduce the risk of cardiovascular disease in those with obesity, while some other cohort studies found that not eating breakfast might increase the risk of coronary heart disease, diabetes and other related diseases. In addition, a number of studies claimed that continuous caloric restriction is associated with the depletion of peripheral immune cells, immune suppression and reduced bone mineral density. In spite of those inconclusive results, on the whole, fasting and caloric restriction in some way do improve the conditions of metabolism, overweight and obesity. Previous studies mostly focused on middle-aged and elderly people, while recent studies in mice show that energy limitation in elderly people could not stop the aging process genetically or metabolically. Therefore, this study aims 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. A pilot study containing around 40 participants will be conducted firstly to assess the feasibility of this intervention plan.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
- First and second year undergraduate students in Sun Yat-sen University.
- BMI≥22 kg/m2.
- Having the time and volunteering to receive the interventions.
- Currently engaged in other weight-lossing studies.
- With secondary obesity induced by medicine or other diseases.
- With high blood pressure, diabetes or other cadiovascular diseases.
- Contraindication to exercise.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise group Exercise Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers. Caloric restriction group Caloric restriction The caloric restriction plan will be designed based on individual basal metabolic rate. Combined intervention group Caloric restriction Participants will receive both exercise and caloric restriction intervention at the same time. Combined intervention group Exercise Participants will receive both exercise and caloric restriction intervention at the same time.
- Primary Outcome Measures
Name Time Method Body weight Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention Body weight change of participants
- Secondary Outcome Measures
Name Time Method Serum lipid levels Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method.
Circulating metabolome Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention To measure the change of circulating metabolome by LC-MS/MS method.
Body composition Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention Skeletal muscle mass and fat mass were measured by body composition analyzers.
Systolic and diastolic blood pressure Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention Sitting systolic and diastolic blood pressure were measured with a validated mercury sphygmomanometer (model XJ1ID, China) and TZ-1 stethoscope.
Fasting plasma glucose Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention Fasting plasma glucose were analyzed by the glucose oxidase method.
Intestinal flora Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention To measure the change of intestinal flora by analyzing feces genome 16S rDNA
Immune inflammation indicators Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention 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.
Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A) Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention 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.
Trial Locations
- Locations (1)
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, China