Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients

Zhejiang University

Status

Active, not recruiting

Conditions

Overweight and Obesity

Impaired Glucose Regulation

Treatments

Other: whole grain porridge

Dietary Supplement: dietary fiber probiotic beverages

Study type

Interventional

Funder types

Other

Identifiers

NCT06475573

2022-0946

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.