Effects of Milk Powder Intervention on Blood Glucose Control and Fluctuation in Middle-aged and Elderly People With Pre-diabetes

NCT06863766 | Not Yet Recruiting

• 1 other identifier: MN-2024-07
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to conduct a 8-week intervention involving one formula milk powder for middle-aged and elderly individuals with pre-diabetes, assessing its impact on blood glucose control and fluctuations in comparison to interventions using regular milk powder.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (3)

• fasting blood glucose

  At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.

  up to 8 weeks

• 2h-piAUC after standardized breakfast

  the positive increment of area under curve in 2 hours after standardized breakfast standardized breakfast, measured by continuous glucose monitoring at baseline, and 8 weeks.

  up to 8 weeks

• TIR (time in range)

  TIR refers to the time when blood glucose is controlled within a reasonable ( target ) range (3.9\~10.0 mmol/L), measured by continuous glucose monitoring at baseline and 8 weeks.

  up to 8 weeks

Secondary Outcomes (7)

• HbA1c

  up to 8 weeks

• weight

  up to 8 weeks

• intestinal bacteria

  up to 8 weeks

• lipid metabolism

  up to 8 weeks

• sleep quality

  up to 8 weeks

Study Arms (2)

fortified formula milk powder group

EXPERIMENTAL

Fortified formula milk powder is supplemented with fiber, bitter gourd powder,mulberry leaves extract, whitekidney beans extract, and probiotics, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day for a duration of 8 weeks.

Dietary Supplement: fortified formula milk powder group

regular milk powder group

PLACEBO COMPARATOR

Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.

Dietary Supplement: regular milk powder group

Interventions

fortified formula milk powder group DIETARY_SUPPLEMENT

Fortified formula milk powder is supplemented with fiber, bitter gourd powder,mulberry leaves extract, whitekidney beans extract, and probiotics, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day for a duration of 8 weeks.

fortified formula milk powder group

regular milk powder group DIETARY_SUPPLEMENT

Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.

regular milk powder group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 75 years, regardless of gender.
• Impaired fasting glucose (5.6 mmol/L ≤ FPG \< 6.9 mmol/L) or glycated hemoglobin (HbA1c) between 5.7-6.4% (39-47 mmol/mol).
• Resided in Guangzhou for the past six months and no plans to relocate or travel outside the city in the next month.
• Signed informed consent form and voluntarily agreed to participate in the project.

You may not qualify if:

• Patients with a confirmed diagnosis of diabetes who are currently taking glucose-lowering medications (e.g., insulin, GLP-1 receptor agonists, or SGLT2 inhibitors).
• Individuals with lactose intolerance or dairy product intolerance.
• Pregnant, planning to become pregnant within the next three months, or currently breastfeeding.
• Weight change \> 5% in the past three months or plans to lose weight or change dietary habits.
• Alcohol consumption \> 40g/day.
• Individuals with communication barriers, cognitive impairments, or other conditions that may prevent them from completing the study procedures.
• Severe diseases that may affect participation in the study, including but not limited to endocrine disorders, severe cardiovascular or cerebrovascular diseases, cancer, metabolic diseases, etc.
• Participation in or current involvement in other clinical trials within the past three months.
• No use of antibiotic medications within the past three months.

Sponsors & Collaborators

• Huilian Zhu: lead

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: April 10, 2025
• Primary Completion: December 20, 2025
• Study Completion: March 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share