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

NCT06552403 | Completed

• 1 other identifier: 5:2 intermittent fasting diet
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Change in metabolic components

  24 weeks after intervention

Study Arms (1)

Modified 5:2 IF diet

EXPERIMENTAL

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

Interventions

A modified 5:2 intermittent fasting diet 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.

Modified 5:2 IF diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants aged 18 to 60 years
• participants with a body mass index (BMI) ≥ 24 kg/m2
• participants engaged in light physical labor and their weight was relatively stable.

You may not qualify if:

• participants taking any medication with an effect on body weight in the three months prior to enrollment;
• participants with liver or kidney dysfunction (liver enzymes ≥ 2 times normal; blood creatinine \> the upper limit of normal);
• participants with a history of cardiovascular disease (e.g., coronary heart disease, stroke);
• participants with malignant tumors;
• women during pregnancy or breastfeeding;
• participants deemed unsuitable by the investigator to participate in this trial.

Sponsors & Collaborators

• Zhejiang Provincial Tongde Hospital: lead

Study Sites (1)

Xiaoli Wang

Hangzhou, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoli Wang

  Zhejiang Provincial Tongde Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 14, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)