Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients

N/AActive Not RecruitingNCT06475573

Second Affiliated Hospital, School of Medicine, Zhejiang University52 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Impaired Glucose Regulation Overweight and Obesity

Interventions

dietary fiber probiotic beveragesDIETARY_SUPPLEMENT

The intervention period lasted for 8 weeks. During this time, Participants received dietary guidance from researchers. The target energy intake was based on the limited energy diet model recommended in the "Chinese Guidelines for Medical Nutrition Therapy of Overweight/Obesity (2021)". Carbohydrates were to account for 55%-60% and fat for 25%-30% of total daily energy intake. Participants in experimental group consumed two 35g sachets of fermented dietary fiber probiotic solid beverages daily, replacing part of the staple food for lunch and dinner.

whole grain porridgeOTHER

The intervention period lasted for 8 weeks. During this time, Participants received dietary guidance from researchers. The target energy intake was based on the limited energy diet model recommended in the "Chinese Guidelines for Medical Nutrition Therapy of Overweight/Obesity (2021)".Participants in control group consumed two 35g sachets of convenient whole grain porridge daily, replacing part of the staple food for lunch and dinner.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

fasting blood glucose

fasting blood glucose after an overnight fast

Time frame: Baseline and after 8-week intervention

2-hour postprandial blood glucose

2-hour postprandial blood glucose after 75g Glucose Tolerance Test

Time frame: Baseline and after 8-week intervention

Secondary Outcomes

Body weight

Time frame: Baseline; after 4-week intervention; after 8-week intervention

body composition

body composition measured by Bioelectrical impedance analysis, including body fat percentage, visceral fat area, skeletal muscle mass

Time frame: Baseline; after 4-week intervention; after 8-week intervention

Lipid profile

Total cholesterol, triglycerides, HDL, LDL

Time frame: Baseline and after 8-week intervention

Data from ClinicalTrials.gov

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