Protein and Micronutrient Intervention for Regulating Androgen Levels and Correcting Lifestyle Associated Effects in Polycystic Ovary Syndrome (PCOS) (MIRACLE-PCOS Study) - An Open label, Interventional, Multicenter, Non-randomized, Single-arm, Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- 1. Assessment of change in dietary intake using 3-day dietary recall
研究概览
简要总结
This is an open label, interventional, multicenter, non-randomized, single-arm, proof of concept study to assess the safety and efficacy of high protein and micronutrient intervention in regulating the androgen levels and correcting lifestyle associated effects in participants with Polycystic ovary syndrome (PCOS).
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the participants.
Total Study Duration: Approximately 6 months
-
Treatment Period: 3 months
-
Follow-up Period: Up to 50 days after 3-months of IP Consumption
Study visits: The study will consist of a total of 08 visits, i.e., 04 physical and 04 telephonic visits.
All eligible participants will undergo clinical assessments, laboratory assessments and subjective assessments. Safety will be assessed throughout the study by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Non-pregnant /non-lactating females. 2) Overweight and Obese participants with BMI range from 23 kg/m2 to 35 kg/m2 3) Participants with HbAlC below 6.5 % (normal and prediabetic participants) 4) Participants with PCOS and with presence of any two of the following parameters (Rotterdam criteria): o Clinical hirsutism (Ferriman-Gallwey score of greater than or equal to 4 to greater than or equal to 8 or as per clinical judgement) or biochemical hyperandrogenism (only total testosterone- greater than 50 ng/dL) o evidence of oligo-anovulation (oligo amenorrhea (cycles more than 35 days apart or less than 8 menses a year) o polycystic appearing-ovarian morphology on ultrasound, with exclusion of other relevant disorders. (Greater than or equal to 20 follicles per ovary in either ovary or greater than or equal to 10 cm3 ovarian volume) 5) Participants with a Menstrual Cycle length of
- •50 day. 6) Participants who have completed a one-month washout period, in case of any hormone treatments within the last 24 weeks.
排除标准
- •Participants with hypothyroidism or hyperthyroidism as confirmed by lab test (T3, T4 and TSH) 2) Participants who have received any drugs to support conception.
- •Participants with presence of other conditions causing ovulatory dysfunction, such as hyperprolactinemia or hyper/hypothyroidism, or androgen excess, such as adrenal hyperplasia or Cushings syndrome / with a suspected adrenal or ovarian tumor secreting androgen.
- •Participants who have undergone major surgery of any organ system in the opinion of PI and defined in terms of factors like significant patient comorbidity, key surgical parameters (long operative duration, organ ischemia, blood loss more than 1000mL, high vasopressor use), post operative metabolic stress response, 30-day morbidity, more than 2% and the need for intermediate or intensive care in the past 1 month.
- •Participants on confounding medications which affect ovarian function including metformin (Participants who were using metformin and who have completed a one-month washout period, can be included in the study) or Using insulin sensitizing drugs or Any pharmacotherapy capable of interfering with glucose metabolism or any drug to support conception.
- •Participants undergoing treatment with products containing inositol in the previous 3 months.
- •Hospitalization for an infectious condition within 4 weeks prior to study entry.
- •Participants who are allergic to the ingredients (Myo-inositol, INS 460 (i), Alpha-lipoic acid, Minerals, Inositol (D-chiro), Vitamins) of the interventional product.
- •Participants actively trying for conception via ART Therapy.
- •Any other condition in the opinion of the Principal Investigator which may interfere with study results and affect the participants safety.
结局指标
主要结局
1. Assessment of change in dietary intake using 3-day dietary recall
时间窗: 1. Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) | 2. Screening Visit (only for TT), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) | 3. Screening Visit (only for HbA1c), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption)
2. Assessment of Androgen-associated outcomes
时间窗: 1. Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) | 2. Screening Visit (only for TT), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) | 3. Screening Visit (only for HbA1c), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption)
3. Assessment of Glucose metabolism outcomes and insulin resistance
时间窗: 1. Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) | 2. Screening Visit (only for TT), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption) | 3. Screening Visit (only for HbA1c), Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption)
次要结局
- Assessment of Androgen-associated outcomes(Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) OR Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption))
- Assessment of characteristics associated with PCOS(Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) AND Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption))
- Assessment of Body Outcomes(Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption))
- Assessment of Lipid metabolism outcomes(Visit 01P (Baseline) and Visit 02P (Within 1 week after 3-months of IP Consumption))
- Assessment of menstrual cycles associated parameters(Visit 01P (Baseline) & Visit 02P (Within 1 week after 3-months of IP Consumption) AND Visit 03P (2-4th day of menses that occur within 50 days after 3-months of IP Consumption))
- Assessment of parameters related to Infertility((a) Size of Ovary by Ultrasound Scanning)
研究者
Dr Simran Sethi
Cliantha Research