Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients

Effect of Fermented Dietary Fiber and Probiotics on the Intervention of Overweight/Obese Patients With Impaired Glucose Regulation

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 Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity; Impaired Glucose Regulation
• Intervention / Treatment: Dietary supplement: dietary fiber probiotic beverages; Other: whole grain porridge

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Consume two 35g sachets of fermented dietary fiber probiotic solid beverages daily, replacing part of the staple food for lunch and dinner.	Dietary supplement: dietary fiber probiotic beverages; 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.
Active Comparator: Control Group; Consume two 35g sachets of convenient whole grain porridge daily, replacing part of the staple food for lunch and dinner.	Other: whole grain porridge; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting blood glucose	fasting blood glucose after an overnight fast	Baseline and after 8-week intervention
2-hour postprandial blood glucose	2-hour postprandial blood glucose after 75g Glucose Tolerance Test	Baseline and after 8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight	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	Baseline; after 4-week intervention; after 8-week intervention
Lipid profile	Total cholesterol, triglycerides, HDL, LDL	Baseline and after 8-week intervention

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pianhong Zhang, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Probiotic; dietary fiber; overweight and obesity; impaired fasting glucose; impaired glucose tolerance
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 2022-0946

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No