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

Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China: A Self-controlled Clinical Trial

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 Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Dietary supplement: A modified 5:2 intermittent fasting diet

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Xiaoli Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body measurements	weight, BMI, and waistline	24 weeks after intervention
glycolipid metabolism indicators	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.	24 weeks after intervention
adipokines	leptin and lipocalin	24 weeks after intervention
inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention	high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-α)	24 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in metabolic components	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.	24 weeks after intervention

Collaborators and Investigators

• Sponsor: Zhejiang Provincial Tongde Hospital
• Investigators: Principal Investigator: Xiaoli Wang, Zhejiang Provincial Tongde Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 5:2 intermittent fasting diet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No