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OpenTrials
Completed

NCT Number: NCT03658187

Assessment of the Acute Effect of IP

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.

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Key information

Conditions

Deficiency Growth Hormone Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vedic Lifesciences Pvt. Ltd

Mumbai, Opp Infinity Mall, 400053, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.

IP

Dietary Supplement

Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.

Primary outcomes

  1. Change in the plasma human growth hormone (hGH) levels in aging individuals

    Time frame: Pre-dose: 0 hours and Post dose: 30, 60, 90,120 mins

    Change in serum hGH levels from baseline

Secondary outcomes

  1. Change on Visual Analogue Score for Fatigue

    Time frame: From Day 0 to Day 1

    Change in Visual Analogue Scale score in IP and placebo.

Sponsors and collaborators

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 5, 2018
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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