Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients

NCT06475573 | Active Not Recruiting

• 1 other identifier: 2022-0946
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Regulation; Overweight and Obesity

Keywords

impaired fasting glucose; impaired glucose tolerance; overweight and obesity; dietary fiber; Probiotic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Body weight

  Baseline; after 4-week intervention; after 8-week intervention

• body composition

  Baseline; after 4-week intervention; after 8-week intervention

• Lipid profile

  Baseline and after 8-week intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Consume two 35g sachets of convenient whole grain porridge daily, replacing part of the staple food for lunch and dinner.

Other: whole grain porridge

Interventions

dietary fiber probiotic beverages DIETARY_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.

Experimental group

whole grain porridge OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Overweight; Obesity; Glucose Intolerance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Pianhong Zhang, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: March 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: October 31, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CN (1)