NCT04275440

Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora

Effects of Caloric Restriction and Exercise on Body Weight, Cardiometabolic Risk Markers, Immune Function, and Intestinal Flora in College Students: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiometabolic Risk
• Weight Loss
• Immune System
• Intestinal Microbiome

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	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.
BEHAVIORAL	Caloric 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).

Timeline

• Start date: 2019-12-06
• Primary completion: 2020-04-05
• Completion: 2020-04-12
• First posted: 2020-02-19
• Last updated: 2021-09-22

Locations

1 site across 1 country: China