NCT07333885已完成不适用
The Impact of Reducose® on Symptoms of Perimenopause and Glycemic Response: a Randomized Controlled Trial
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Glycemic response following test meal
研究概览
简要总结
The purpose of this double-blind, randomized, placebo-controlled trial is to. evaluate daily Reducose® (mulberry leaf extract) supplementation taken with the two largest meals for 12 weeks on improving glycemic response and perimenopausal symptoms in women aged 40-60 years. Glycemic response is measured using Dexcom Stelo continuous glucose monitors during standardized test meals, and menopausal symptoms and sleep/quality-of-life outcomes are assessed using validated surveys administered through the Chloe app in a decentralized U.S. study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study is a randomized, double-blind, placebo-controlled trial. Participants, care providers, investigators, and outcomes assessors are blinded to intervention assignment. Study products are labeled as Product A or Product B, and the randomization code is maintained by the sponsor and only broken in the event of a serious adverse event.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants assigned female at birth (aged 40-60 years) will be recruited for the study.
- •Females ages 40-60 who are weight stable and with a self- reported Body Mass Index (BMI) between 18.5 to 35 kg/m
- •Willing to maintain their existing dietary and physical activity patterns throughout the study period.
- •Have received a medical physical screening (annual physical) within the last 12 months where blood markers for diabetes were taken and results were within the healthy range.
- •Self-reported >40yrs in age and experiencing irregular periods.
- •Willing and able to comply with the study protocol.
- •Has given voluntary informed consent to participate in the study.
- •Not currently using hormone replacement therapy (HRT) and/or >3months since their last hormone treatment.
- •Experiencing menopause symptoms and meets the minimum score of 12/60 on the Greene Climacteric Scale (GCS).
- •Own or have constant access to a smart phone and the apple or android app stores and are willing and able to download the Dexcom and Chloe apps and accept their respective privacy policies.
- •Willing to practice a reliable method of non-hormonal contraception for the duration of the study.
- •In good general health at the time of screening (Investigator discretion).
- •Able to read, understand, and provide informed consent in English.
- •Able to receive shipment of the product at an address within the United States.
- •Able to complete study assessments over the course of up to 12 weeks.
排除标准
- •Participants assigned male at birth.
- •Aged > 60 or < 40 years.
- •Pregnant or lactating.
- •Body mass index (BMI) > 35kg/m2 or < 18.5kg/m2
- •Fasting blood glucose >126mg/dL and/or HbA1c >6.5% reported in routine medical physical screening within the last 12-months.
- •Known history of diabetes mellitus (Type I/II) or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
- •Currently using hormone replacement therapy (HRT) or had hormone therapy in the last 3 months.
- •Postmenopausal, experiencing amenorrhea for >12months.
- •Underwent medically induced or surgical menopause.
- •History of hysterectomy or full or partial oophorectomy.
- •Any known food allergy or intolerance including mulberry extract.
- •Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or influence digestion and absorption of nutrients, including thyroid conditions, active inflammatory bowel disease (Crohn's disease or ulcerative colitis) and incretin mimetics (GLP-1, Semaglutide, Dulagluetide, Tirzepatide, etc.)
- •Previously undergone bariatric surgery.
- •Use steroids, protease inhibitors, antipsychotics, antidepressants (including selective serotonin reuptake inhibitors and monoamine oxidase inhibitors) (all of which have effects on glucose metabolism and body fat distribution).
- •Significant or untreated medical and/or psychiatric disorders including but not limited myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, renal failure and serious renal diseases, undergoing dialysis, chronic active hepatitis, acute hepatitis, cirrhosis of liver, AIDS, malignancy or neurological disorders including epilepsy, recent cerebrovascular disease or recent traumatic brain injury.
- •Alcohol intake above recommendations (>2 standard alcoholic drinks per day) or drug abuse or dependence within the past 6 months.
- •Currently smoke tobacco and cannabis products (including vaping).
- •Consuming extremely restrictive diet currently or within past 3 months.
- •Weight has varied significantly (+/- 5 lbs) in the past 3 months.
- •Cognitively impaired and/or who are unable to give informed consent.
- •Taking daily medications or dietary supplements that have a significant effect on blood glucose control either as a primary function or side effect.
- •Subject to a major medical, surgical or major depressive or psychiatric event requiring hospitalization within the preceding 3 months.
- •Use of over the counter medications like Herbal Supplements: Black Cohosh, Dong Quai, Maca Root, Red Clover, Chaste Tree Berry (Vitex), Soy Isoflavones, Ashwagandha; OTC Non-Herbal Supplements: DHEA, Progesterone Cream (Bioidentical), Melatonin.
- •Participation in any other clinical research trial within 30 days prior to randomization.
- •Do not have a personal smartphone, internet access, or unwilling to download Chloe or use a Dexcom Continuous Glucose Monitoring Device.
- •Are unlikely for any reason to be able to comply with the study protocol, do not provide informed consent, or considered unsuited for participation in the study by the Principal Investigator.
研究组 & 干预措施
Reducose® Mulberry Leaf Extract
Experimental
干预措施: Reducose® (Mulberry leaf extract) (Dietary Supplement)
Matching Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Glycemic response following test meal
时间窗: Baseline and end-of-study test meals (Days 3,7,91).
Postprandial glycemic response measured as 0-120-minute incremental area under the curve (iAUC) from interstitial glucose readings captured by Dexcom Stelo CGM.
Glycemic response following test meal
时间窗: Baseline and end-of-study test meals (Days 10, 14, and 98).
Postprandial glycemic response measured as 0-120-minute incremental area under the curve (iAUC) from interstitial glucose readings captured by Dexcom Stelo CGM.
次要结局
- Time to peak glucose (Tmax) following test meal(Days 3, 7 and 91.)
- Peak glucose concentration (Cmax) following test meal(Days 3, 7, and 91.)
- Fasting blood glucose prior to test meals(Days 7 and 91.)
- Mean Amplitude of Glycemic Excursions (MAGE)(Days 0-16 and 80-95)
- Nighttime Gross Coefficient of Variation (%CV)(Days 0-16 and 80-95)
- Menopausal symptoms (Greene Climacteric Scale total score)(Days 7, 35, 63, 91)
- Sleep disturbance (PROMIS Sleep Disturbance Short Form-6a)(Day 5 and 91)
- Quality of Life questionnaire(Day 5 and 91)
- Product Experience Questionnaire(Day 91)
- Time to peak glucose (Tmax) following test meal(Days 10, 14, and 98.)
- Peak glucose concentration (Cmax) following test meal(Days 10, 14, and 98.)
- Fasting blood glucose prior to test meals(Days 14 and 98.)
- Mean Amplitude of Glycemic Excursions (MAGE)(Baseline (Days 7-14), Week 1 (Days 14-21), Week 11 (Days 85-92), Week 12 (Days 92-98).)
- Nighttime Gross Coefficient of Variation (%CV)(Baseline (Days 7-14), Week 1 (Days 14-21), Week 11 (Days 85-92), Week 12 (Days 92-98).)
- Menopausal symptoms (Greene Climacteric Scale total score)(Screening/Day 0, Days 14, 42, 70, 98.)
- Sleep disturbance (PROMIS Sleep Disturbance Short Form-6a)(Baseline (Day 5) and end of study (Day 98).)
- Quality of Life questionnaire(Baseline (Day 5) and end of study (Day 98).)
- Product Experience Questionnaire(End of study (Day 98))
研究者
研究点 (3)
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