NCT06897462已完成不适用
Effect of Science Research Wellness Ndo1 on Glycaemia in Adults With Pre-diabetes
Wellizen Australia1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Serum Hemoglobin A1C (HbA1c) concentration
研究概览
简要总结
The objective of this study is to test the effect of 12 weeks of supplementation SRW Ndo1 on metabolic health and general health in adults with prediabetes. The primary question it aims to answer are:
- How does SRW Ndo1 affect the Haemoglobin A1C (HbA1C) test outcome for adult individuals?
- How does SRW Ndo1 affect the body measures and blood pressures of adult individuals?
Investigators will compare the supplement to a placebo (a look-alike substance that contains no supplement) to see if SRW Ndo1 works to support normal blood sugar metabolism.
Participants will:
- Take supplement SRW Ndo1, two capsules a day for 12 weeks.
- Be asked to refrain from changing their diet and lifestyle drastically during the study and to refrain from starting new health supplements during the study.
- Visit the clinic at the start and the end of intervention for a blood test (8 hour fasting required prior to test)
- Keep a diary of their symptoms or adverse events during intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and over.
- •Prediabetes, defined as fasting plasma glucose of 6.1-6.9 mmol/L and/or HbA1c of 5.7-6.4% and/or 2 h plasma glucose of 7.8-11.0 mmol/L after ingestion of 75 g of oral glucose load. Blood tests conducted within 3 months before randomisation will be accepted.
- •Able to read and write English.
- •Has access to internet.
- •Provided informed consent to participate in the study.
排除标准
- •Has a medical condition known to affect the glycaemia.
- •Regular intake of a health supplement with effects on glycaemia.
- •Currently participating in another trial/study of a supplement or drug.
- •Has any known food or allergy or intolerances to the ingredients of the intervention.
- •Pregnant, trying to conceive or breastfeeding.
- •Has any current substance abuse (including tobacco, alcohol and recreational drugs) or currently in substance withdrawal.
- •Moderate to severe medical conditions (defined as a significant impact on social areas of functioning).
- •Any medical conditions that was not stable over the last 3 months.
- •Taking any prescription medication known to affect glycaemia or had a change in their medication within the last 3 months.
- •Currently taking celiprolol, metformin, or any angiotensin-converting enzyme inhibitor medications.
- •Major medical or surgical event requiring hospitalization within the last 3 months.
- •Any other medical reason that may make participation in this study pose a risk to the participant, including potential herb-drug interactions, at the discretion of the study medical supervisor.
研究组 & 干预措施
SRW Ndo1
Experimental
Active arm
The investigational product (IP) is a health supplement that contains 80 mg of dahlia4® (Dahlia pinnata extract), 80 mg of Eriomin® (Citrus limon extract), and 100 mg of Mulberry leaf extract (with 5% 1-deoxynojirimycin) per capsule. Excipients include Microcrystalline cellulose, Magnesium stearate, and Colloidal silicon dioxide.
Participants will take two capsules of Ndo1 per day, before dinner, with water, for 12 weeks.
干预措施: SRW Ndo1 (Dietary Supplement)
结局指标
主要结局
Serum Hemoglobin A1C (HbA1c) concentration
时间窗: From enrollment to the end of treatment at 12 weeks
Measured in mmol/mol. Normal range: \<5.7
次要结局
- Fasting plasma glucose concentration(From enrollment to the end of treatment at 12 weeks)
- Weight(From enrollment to the end of treatment at 12 weeks)
- Body Mass Index (BMI)(From enrollment to the end of treatment at 12 weeks)
- Waist circumference(From enrollment to the end of treatment at 12 weeks)
- Blood lipids(From enrollment to the end of treatment at 12 weeks)
- Liver functions test(From enrollment to the end of treatment at 12 weeks)
- Hs-CRP test(From enrollment to the end of treatment at 12 weeks)
- Systolic and diastolic blood pressure(From enrollment to the end of treatment at 12 weeks)
- Energy questionnaire(From enrollment to the end of treatment at 12 weeks)
- Hunger and satiety questionnaire(From enrollment to the end of treatment at 12 weeks)
- Mood questionnaire(From enrollment to the end of treatment at 12 weeks)
- Gastrointestinal symptoms questionnaire(From enrollment to the end of treatment at 12 weeks)
- Hypoglycemia events frequency questionnaire(From enrollment to the end of treatment at 12 weeks)
研究者
研究点 (1)
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