Clinical trial NCT04275440: Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk
Weight Loss
Immune System
Intestinal Microbiome
Keywords: Caloric Restriction
Exercise
Young Adult
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Secondary outcomes:
measure: Body composition
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
measure: Serum lipid levels
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
measure: Fasting plasma glucose
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
measure: Systolic and diastolic blood pressure
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
measure: Immune inflammation indicators
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
measure: Intestinal flora
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
measure: Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
measure: Circulating metabolome
timeFrame: Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: 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
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yanna Zhu, M.D
role: PRINCIPAL_INVESTIGATOR
References: