A study to evaluate the effect of GenF20 Plus on IGF-1 levels in normal to overweight adult volunteers with poor quality of sleep, decreased memory, decreased libido and low energy levels

Phase 2

Completed

Registration Number: CTRI/2011/06/001784

Lead Sponsor: eading Edge Marketing

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1) Adults with any 2 of the following conditions: poor quality of sleep, decreased memory, decreased libido and low energy levels ? with the affected parameters (of sleep, memory, libido and energy levels) perceived to be of grade 1 or 2 on a Likert scale. The above conditions should have been present since at least 1 month.

2) Body Mass Index between 18.5 to 29.9 kg/m2

3) Willing to give written informed consent and abide with trial procedures and come for the follow up visits

4) Women willing to practice suitable contraception (except oral contraceptives) during the study

5) Willing to continue current lifestyle practices with no modifications (in diet and exercise ) during the study period

Exclusion Criteria

1) Adults with uncontrolled conditions of diabetes, hypertension, hypothyroidism, hyperthyroidism

2) Hepatic or renal impairment

3) Women on oral contraceptives, estrogen supplements and corticosteroids

4) Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, a history of ischemic heart disease (as evident from ECG), history of stroke and/or TIA.

5) Women with estrogen sensitive disorders like breast cancer, uterine cancer, ovarian cancer, endometriosis and uterine fibroids

6) Debilitating neurological or psychiatric disorders including seizure disorders and depression.

7) Known hypersensitivity or allergy to one or more of the ingredients of the IP.

8) Known history of allergy to milk and milk products.

9) Recent ( 1 month) participation in a clinical trial

10) Any condition likely to hinder the compliance with the protocol.

11) Heavy smoking (more than 10 cigarettes per day) or chronic alcoholics.

12) Pregnant and lactating women

13) Subjects who have begun an exercise and/or diet regimen within 30 days of the screening visit

14) Known cases of acromegaly

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin Growth Factor - 1Timepoint: Screening Visit & Day 84

Secondary Outcome Measures

Name	Time	Method
1)To assess the effect of the IP on the quality of life sleep, memory, libido and energy using QoL questionnaire <br/ ><br>Timepoint: 1) Quality of Life Questionnaire - Day -5, Day 0, Day 28, Day 56, Day 84 <br/ ><br>2) Monitoring of AE/SAE - Day 1, Day 28, Day 56, Day 84