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

Sun Yat-sen University

Status: Completed

Conditions: Weight Loss; Intestinal Microbiome; Cardiometabolic Risk; Immune System

Treatments: Behavioral: Caloric restriction; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04275440

ZDGW[2019]127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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195 participants in 3 patient groups

Exercise group

Experimental group

Description:

Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.

Treatment:

Behavioral: Exercise

Caloric restriction group

Experimental group

Description:

The caloric restriction plan will be designed based on individual basal metabolic rate.

Treatment:

Behavioral: Caloric restriction

Combined intervention group

Experimental group

Description:

Participants will receive both exercise and caloric restriction intervention at the same time.

Treatment:

Behavioral: Exercise

Behavioral: Caloric restriction