Clinical trial NCT06475573: Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients
Official title: Effect of Fermented Dietary Fiber and Probiotics on the Intervention of Overweight/Obese Patients With Impaired Glucose Regulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Impaired Glucose Regulation
Overweight and Obesity
Keywords: impaired fasting glucose
impaired glucose tolerance
overweight and obesity
dietary fiber
Probiotic
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: fasting blood glucose
timeFrame: Baseline and after 8-week intervention
measure: 2-hour postprandial blood glucose
timeFrame: Baseline and after 8-week intervention
Secondary outcomes:
measure: Body weight
timeFrame: Baseline; after 4-week intervention; after 8-week intervention
measure: body composition
timeFrame: Baseline; after 4-week intervention; after 8-week intervention
measure: Lipid profile
timeFrame: Baseline and after 8-week intervention
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Pianhong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: