Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity; Impaired Glucose Regulation
• Interventions: Other: whole grain porridge; Dietary Supplement: dietary fiber probiotic beverages

• Registration Number: NCT06475573
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Impaired glucose regulation (IGR), encompassing impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), represents a crucial stage in the progression to type 2 diabetes. Characterized by a state of compensatory glucose dysmetabolism, IGR is closely linked to overweight/obesity and can be reversed through lifestyle interventions. Timely intervention during this stage can promote weight loss, delay or prevent the onset and development of diabetes, and reduce the risk of cardiovascular diseases, chronic kidney disease, and all-cause mortality.

Current treatment approaches for overweight/obese IGR patients include dietary and physical activity modifications, pharmacotherapy, and bariatric surgery. However, individual responses to these interventions vary considerably. Dietary fiber, essential for maintaining normal gastrointestinal function, has been associated with an increased risk of various diseases, including colorectal cancer, cardiovascular diseases, obesity, metabolic syndrome, and type 2 diabetes, when consumed in inadequate amounts. Conversely, the gut microbiota plays a pivotal role in diabetes development and progression. Probiotics, potentially through the stimulation of short-chain fatty acid production and the induction of gut hormone secretion that influences blood glucose levels, may exert beneficial effects by enhancing immune modulation, increasing anti-inflammatory cytokine production, reducing intestinal permeability, and mitigating oxidative stress.

Therefore, 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.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-05-31
• Status Verified: 2024-06
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	whole grain porridge	Consume two 35g sachets of convenient whole grain porridge daily, replacing part of the staple food for lunch and dinner.
Experimental group	dietary fiber probiotic beverages	Consume two 35g sachets of fermented dietary fiber probiotic solid beverages daily, replacing part of the staple food for lunch and dinner.

Primary Outcome Measures

Name	Time	Method
fasting blood glucose	Baseline and after 8-week intervention	fasting blood glucose after an overnight fast
2-hour postprandial blood glucose	Baseline and after 8-week intervention	2-hour postprandial blood glucose after 75g Glucose Tolerance Test

Secondary Outcome Measures

Name	Time	Method
body composition	Baseline; after 4-week intervention; after 8-week intervention	body composition measured by Bioelectrical impedance analysis, including body fat percentage, visceral fat area, skeletal muscle mass
Body weight	Baseline; after 4-week intervention; after 8-week intervention	Body weight
Lipid profile	Baseline and after 8-week intervention	Total cholesterol, triglycerides, HDL, LDL

Trial Locations

Locations (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China