Assessment of the Acute Effect of IP

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

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.

Study Overview

• Status: Completed
• Conditions: Deficiency Growth Hormone
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: IP

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Opp Infinity Mall
    • Mumbai, Opp Infinity Mall, India, 400053
      • Vedic Lifesciences Pvt. Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: Placebo; Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.; Dietary supplement: IP; Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
Experimental: 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.	Dietary supplement: Placebo; Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.; Dietary supplement: IP; Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 1, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DM/171201/HGH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No