Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora

Sun Yat-sen University

Status: Unknown

Conditions: Intestinal Microbiome; Cardiometabolic Risk; Executive Function

Treatments: Behavioral: Exercise; Behavioral: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04834687

ZDGW[2021]044

Details and patient eligibility

About

The purpose of this study is to estimate the effects of diet and exercise interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.

Full description

In recent decades, unhealthy dietary patterns and insufficiency of physical activity have brought negative effects on human health, such as rapid increasing incidence of obesity, metabolic cardiovascular diseases, and mental disorders. The first line of prevention and therapy for these diseases is proper diet and lifestyle interventions. A series of studies conducted in vivo and vitro have shown that high-fiber diets and time-restricted eating present benefits in weight loss, reducing cardiovascular disease risk, and improving cognitive function. While, there is also a randomized controlled trial do not observe the effects of time-restricted eating on weight loss and decrease of metabolic risks. Meanwhile, few studies have examined the effects of high-fiber diets or time-restricted eating on executive function. Additionally, previous studies on high-fiber diets and time-restricted eating focused on middle-aged or elderly populations with some features of metabolic syndrome, while the effects on healthy young populations are unclear. More importantly, there are a small amount of studies exploring the combined effects of time-restricted eating and physical activity on metabolism and cognitive function. Therefore, our study is to estimate the effects of diet (high-fiber diets and time-restricted eating) and exercise (rope-skipping) interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.

Enrollment: 200 estimated patients

Sex: All

Ages: 17 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• First and second year undergraduate students in Sun Yat-sen University.
• BMI≥22 kg/m^2.
• Keeping weight stable for 3 months prior to study start (weight fluctuation <5kg).
• Having the time and volunteering to receive the interventions.

Exclusion criteria

• Currently engaged in other weight-loss studies.
• With high blood pressure, diabetes or other cardiovascular diseases.
• With secondary obesity induced by medicine or other diseases.
• Contraindication to exercise.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

Rope-skipping 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

Diet intervention group

Experimental group

Description:

Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.

Treatment:

Behavioral: Diet

Combined intervention group

Experimental group

Description:

Participants will receive both rope-skipping and diet interventions at the same time.

Treatment:

Behavioral: Exercise

Behavioral: Diet

Control group

No Intervention group

Description:

Participants would be required to maintain existing diet patterns and physical activity levels.