CTRI/2024/01/061726已完成4 期
A Randomized, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To assess the effect of IP on Glucose Metabolism as assessed by change in serum fasting glucose levels
研究概览
简要总结
The present study is a randomized, placebo-controlled, feasibility study to evaluate efficacy of dietary ingredients in vitality & metabolic factors in healthy individuals. Approximately 54 subjects aged between ≥ 40 and ≤ 60 years will be screened and 36 participants (12 in each arm) are to be randomized. Both the IP and placebo study arms will have 10 completed subjects in each arm after accounting for the screening failure and dropout/withdrawal rate of 30% and 17% respectively (Total 30 completers). The treatment duration for all the study subjects will be 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Physically active males and females aged more than or equal to 40 and less than or equal to 60 years.
- •Individuals with BMI more than or equal to 24.5 and less than equal to 34.9 kg per metre square.
- •Individuals with Fatigue Symptom Severity Score more than equal to 36 and less than or equal to
- •Individuals with Perceived Stress Score more than or equal to
- •Having atleast 2 of the following 5 metabolic risk factors:.
- •Waist circumference: In Men, More than or equal to 102 cm (40.15 inches) and in women more than or equal to 88 cm (34.65 inches).
- •Triglycerides More than 150 mg per dL.
- •Systolic blood pressure (SBP) more than or equal to 130 mm Hg and / or Diastolic blood pressure (DBP) more than or equal to 85 mm Hg.
- •Fasting blood glucose more than or equal to 125 mg per dL.
- •HDL level: In men, less than 40 mg per dL and in Women less than 50 mg per dL.
- •Individuals willing to provide signed consent.
排除标准
- •Individuals on strict vegetarian diet.
- •Individuals with fasting blood sugar more than or equal to 160 mg per dl.
- •Individuals currently hospitalized or planned for admission.
- •Individuals currently undergoing treatment with any other drugs such as insulin, corticoids, and non-steroidal anti-inflammatory drugs for more than 15 days.
- •Individuals undergoing treatment of chemotherapy and/or suffering from AIDS, hepatitis, pregnancy are precluded from the study.
- •Individuals allergic to components of this nutraceutical formulation.
- •Use of medications in the last 2 weeks prior to the pre-baseline period.
- •This does not include birth control pills or standard multi-vitamin or mineral supplements.
- •Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
- •Abnormal Thyroid Stimulating Hormone (TSH) value which is less than 0.40 or more than 4.50 micro IU per mL.
- •Diagnosed cases of Type II Diabetes Mellitus with medication.
- •Hypertensive defined as SBP more than or equal to 160 mm Hg and or DBP more than or equal to 100 mm Hg with anti-hypertensives.
- •Individuals taking anti-hypertensives
- •Individuals with dyslipidemia on medication.
- •Females in peri-menopausal state (Irregular menstrual period in last 6 months).
- •Females on Hormone Replacement Therapy.
- •Use of another investigational product within 3 months of the screening visit.
- •History of any significant neurological and psychiatric condition which may affect the participation and inference of the study’s end points.
- •Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- •High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men.
- •Females who are pregnant or planning to be pregnant or lactating or taking any oral contraceptives.
- •Any condition that could, in the opinion of the investigator, preclude the individual’s ability to successfully and safely complete the study or that may confound study outcomes.
结局指标
主要结局
To assess the effect of IP on Glucose Metabolism as assessed by change in serum fasting glucose levels
时间窗: Day 0 and Day 90
次要结局
- To assess the effect of IP on Fat metabolism as assessed by serum lipid profile(Day 0 and Day 90)
- To assess the effect of IP on physical energy as assessed by energy VAS(Day 0, Day 14, Day 30, Day 60 and Day 90)
- To assess the effect of IP on Fatigue level as assessed by Fatigue Severity Scale (FSS)(Day 0, Day 14, Day 30, Day 60 and Day 90)
- To assess the effect of IP on Perceived immune status as assessed by Immune Status Questionnaire Scale(Day 0, Day 30, Day 60 and Day 90)
- To assess the effect of IP on Sleep as assessed by Pittsburg Sleep Quality Index(Day 0, Day 14, Day 30, Day 60 and Day 90)
- To assess the effect of IP on Stress perception as assessed by the Cohen Perceived Stress score(Day 0, Day 14, Day 30, Day 60 and Day 90)
- To assess the efficacy of IP on Future assessment of vitality related biomarkers (blood sample will be collected and analyzed post-hoc)(Day 0, Day 30 and Day 90)
研究者
Dr Shalini Srivastava
Vedic Lifesciences Pvt. Ltd.
研究点 (2)
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