Effects of Caloric Restriction and Exercise on Body Weight, Cardiometabolic Risk Markers, Immune Function, and Intestinal Flora in College Students: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiometabolic Risk
- Sponsor
- Sun Yat-sen University
- Enrollment
- 195
- Locations
- 1
- Primary Endpoint
- Body weight
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Yanna Zhu
Associate Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •First and second year undergraduate students in Sun Yat-sen University.
- •BMI≥22 kg/m
- •Having the time and volunteering to receive the interventions.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Body weight
Time Frame: 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 Outcomes
- Serum lipid levels(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
- Circulating metabolome(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
- Body composition(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
- Systolic and diastolic blood pressure(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
- Fasting plasma glucose(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
- Intestinal flora(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
- Immune inflammation indicators(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
- 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)