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

Официальное название

Effects of Daily Supplementation With Milk Powder on Blood Glucose Control and Fluctuation in Middle-aged and Older Adults: A Randomized Control Trial

Обзор

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.

Вмешательства

• Пищевая добавка fortified formula milk powder group
  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.
• Пищевая добавка regular milk powder group
  Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.

Первичные конечные точки

• fasting blood glucose [Срок оценки: up to 8 weeks]
• 2h-piAUC after standardized breakfast [Срок оценки: up to 8 weeks]
• TIR (time in range) [Срок оценки: up to 8 weeks]

Вторичные конечные точки (7)

• HbA1c [Срок оценки: up to 8 weeks]
• weight [Срок оценки: up to 8 weeks]
• intestinal bacteria [Срок оценки: up to 8 weeks]
• lipid metabolism [Срок оценки: up to 8 weeks]
• sleep quality [Срок оценки: up to 8 weeks]
• blood pressure [Срок оценки: up to 8 weeks]
• Continuous Glucose Monitoring (CGM) Data [Срок оценки: up to 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06863766 · MN-2024-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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