Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China

NCT ID: NCT06552403

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-31

Brief Summary

This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.

Detailed Description

There are fewer studies on the influence of dietary interventions on the Chinese populations with obesity, and the degree of obesity, body fat distribution, dietary pattern and structure, and metabolic status of populations with obesity are different between the Chinese and European populations. The effects of a 5:2 IF dietary intervention on the Chinese population with overweight or obesity are unclear. Therefore, this study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.

Conditions

Overweight or Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified 5:2 IF diet

The modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day.

Group Type: EXPERIMENTAL

A modified 5:2 intermittent fasting diet

Intervention Type: DIETARY_SUPPLEMENT

The modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day.

Interventions

A modified 5:2 intermittent fasting diet

The modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. participants aged 18 to 60 years

2. participants with a body mass index (BMI) ≥ 24 kg/m2

3. participants engaged in light physical labor and their weight was relatively stable.

Exclusion Criteria

1. participants taking any medication with an effect on body weight in the three months prior to enrollment;

2. participants with liver or kidney dysfunction (liver enzymes ≥ 2 times normal; blood creatinine > the upper limit of normal);

3. participants with a history of cardiovascular disease (e.g., coronary heart disease, stroke);

4. participants with malignant tumors;

5. women during pregnancy or breastfeeding;

6. participants deemed unsuitable by the investigator to participate in this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Provincial Tongde Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaoli Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoli Wang

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Provincial Tongde Hospital

Locations

Xiaoli Wang

Hangzhou, , China

Countries

China

Other Identifiers

5:2 intermittent fasting diet

Identifier Type: -

Identifier Source: org_study_id