Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients (NCT06475573) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients
China52 participantsStarted 2023-03-01
Plain-language summary
This study aims to investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Age 18-65 years old
* Meet the criteria for impaired glucose regulation according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)":
IFG: Fasting blood glucose ≥ 6.1 mmol/L and \< 7.0 mmol/L IGT: 2-hour postprandial glucose ≥ 7.8 mmol/L and \< 11.1 mmol/L
* Meet the Asia-Pacific criteria for overweight and obesity: 23 kg/m2 ≤ BMI
* Signed informed consent
Exclusion Criteria:
* Patients diagnosed with diabetes or currently undergoing diabetes treatment
* Patients who have received weight loss medication or surgery in the past 3 months
* Patients who are taking corticosteroids or thyroid hormones
* Patients with secondary obesity caused by endocrine, genetic, metabolic, or central nervous system diseases
* Patients with severe liver function or abnormal kidney function
* Patients with diseases that affect food digestion and absorption
* Patients with cardiovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy, etc.
* Patients with active tuberculosis, AIDS, and other infectious diseases
* Pregnant or breastfeeding women
* Patients with limb disabilities or other conditions that the clinical investigator deems inappropriate for participation in the study.
What they're measuring
1
fasting blood glucose
Timeframe: Baseline and after 8-week intervention
2
2-hour postprandial blood glucose
Timeframe: Baseline and after 8-week intervention
Trial details
NCT IDNCT06475573
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University