Assessment of the Acute Effect of IP

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Acute Effect of IP on hGH Levels in Aging Adults

Conditions
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Deficiency Growth Hormone

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: IP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Placebo<br>* Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.<br>Dietary Supplement: IP<br>* Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.<br>|
| Experimental: IP<br>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. | Dietary Supplement: Placebo<br>* Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.<br>Dietary Supplement: IP<br>* Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the plasma human growth hormone (hGH) levels in aging individuals | Change in serum hGH levels from baseline | Pre-dose: 0 hours and Post dose: 30, 60, 90,120 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Visual Analogue Score for Fatigue | Change in Visual Analogue Scale score in IP and placebo. | From Day 0 to Day 1 |