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NCT Number: NCT06552403

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

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.

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Key information

Conditions

Overweight or Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiaoli Wang

Hangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. body measurements

    Time frame: 24 weeks after intervention

    weight, BMI, and waistline

  2. glycolipid metabolism indicators

    Time frame: 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.

  3. adipokines

    Time frame: 24 weeks after intervention

    leptin and lipocalin

  4. inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention

    Time frame: 24 weeks after intervention

    high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-α)

Secondary outcomes

  1. Change in metabolic components

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial Tongde Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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