Cardiometabolic Risk, Immune System, Intestinal Microbiome, Weight Loss
Conditions
Keywords
Caloric Restriction, Exercise, Young Adult
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.
Interventions
BEHAVIORALExercise
Rope-skipping exercise for three times a week (90 minutes each time, and there is a 10 min break after 20 min Rope skipping). Exercise bracelet and smart bracelet would be used to record the energy consumption throughout the study.
BEHAVIORALCaloric restriction
1. In the first two weeks, participants would reduce their daily energy intake to 100% -110% of his or her basal metabolic energy under instruction, and stick to it till the end of the intervention. 2. According to the dietary recommendation proposed by Chinese government, participants are required to take in cereals, vegetables, fruits, meat and eggs, while minimize the consumption of sugar-sweeten beverages. 3. Participants are instructed to arrange their three meals according to the recommended energy distribution (3:4:3).
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed