A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Acute Effect of IP on hGH Levels in Aging Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in the plasma human growth hormone (hGH) levels in aging individuals
研究概览
简要总结
It is a nutraceutical system, consisting of oral tablet and an oral spray called Alpha GPC, which helps your body naturally restore the HGH levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females having age between 40-60 years (both inclusive)
- •BMI ≥25 and ≤29.9 kg/m2
- •FBS ≤ 120 mg/dl
- •Serum hGH levels ≤0.94 ng/ml in females and ≤0.12 in males
- •Thyroid Stimulating Hormone ≥ 0.35 and ≤ 5.55 mIU/ml
排除标准
- •History of thyroid disorder (Hyper/Hypo).
- •Smokers having at least 1 cigarette per day.
- •Known hypersensitivity or allergy to one or more of the ingredients of the IP
- •Participant suffering from primary or secondary insomnia with/without active treatment.
- •Alcoholics as defined by consumption of more than 2 standard alcoholic drinks (more than 30 ml/ day) for past 3 months.
研究组 & 干预措施
Placebo
2 tablets orally with water and 2 ml of liquid spray to be kept for 30 sec sublingually, before swallowing. To be taken half an hour before dinner prior to the day of site visit.
干预措施: Placebo (Dietary Supplement)
Placebo
2 tablets orally with water and 2 ml of liquid spray to be kept for 30 sec sublingually, before swallowing. To be taken half an hour before dinner prior to the day of site visit.
干预措施: IP (Dietary Supplement)
IP
2 tablets orally with water and 2 ml of liquid spray to be kept for 30 sec sublingually, before swallowing. To be taken half an hour before dinner prior to the day of site visit.
干预措施: Placebo (Dietary Supplement)
IP
2 tablets orally with water and 2 ml of liquid spray to be kept for 30 sec sublingually, before swallowing. To be taken half an hour before dinner prior to the day of site visit.
干预措施: IP (Dietary Supplement)
结局指标
主要结局
Change in the plasma human growth hormone (hGH) levels in aging individuals
时间窗: Pre-dose: 0 hours and Post dose: 30, 60, 90,120 mins
Change in serum hGH levels from baseline
次要结局
- Change on Visual Analogue Score for Fatigue(From Day 0 to Day 1)