NCT06475573

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Impaired Glucose Regulation
• Overweight and Obesity

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-05-31
• Completion: 2024-10-31
• First posted: 2024-06-26
• Last updated: 2024-06-26

Locations

1 site across 1 country: China