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

Not Applicable

Completed

• Conditions: Overweight or Obesity

• Registration Number: NCT06552403
• Lead Sponsor: Zhejiang Provincial Tongde Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-07-31
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-11
• Last Update Submitted: 2024-08-11
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
glycolipid metabolism indicators	24 weeks after intervention	fasting plasma glucose (FPG), fasting plasma insulin (FPI), fasting C-peptide (FCP), triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and uric acid.
inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention	24 weeks after intervention	high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-α)
body measurements	24 weeks after intervention	weight, BMI, and waistline
adipokines	24 weeks after intervention	leptin and lipocalin

Secondary Outcome Measures

Name	Time	Method
Change in metabolic components	24 weeks after intervention	Participants' metabolic components were analyzed by serum metabolomics analysis. The ultra-high performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) (Agilent 1290, Agilent Technologies, Inc., USA) was applied to identify metabolites.

Trial Locations

Locations (1)

Xiaoli Wang; 🇨🇳 Hangzhou, China