A double blind clinical Study to Evaluate Efficacy and Safety of a novel formulation on Weight Management in Healthy Volunteers

Phase 2

Completed

Conditions: Over weight

Registration Number: CTRI/2013/08/003891

Lead Sponsor: Iovate Health Sciences International Inc

Brief Summary: The study under trial is to investigate the efficacy of novel formulation containing two Natural bioactive compound curcumin and Alpha lipoic acid which helps in providing a solution to a problem of increasing body weight to the over-weight subjects. Curcumin is a polyphenol extracted from the rhizomes of turmeric (*Curcuma longa L*). It is known for its beneficial health effects attributed to anti-inflammatory, anti-oxidant and hypolipidemic properties. Alpha lipoic acid is an organo-sulfur compound derived from caprylic acid that acts as a co-factor of mitochondrial enzymes. It is synthesized in the human body, but is also widely distributed in foods and has attracted much interest because of its anti-oxidant effects and therapeutic potential. In several human studies for weight management using curcumin and Alpha lipoic acid has demonstrated to be both safe and effective for long-term use. Body weight, BMI, body composition and Waist hip ratio will be assessed in the present study to check the efficacy of study medication.

The purpose of this study is to assess the clinical effectiveness of Alpha lipoic acid in combination with curcumin versus placebo in over-weight subjects whose BMI falls within the range of 28-32. Enrolled subjects will receive alphalipoic acid in combination with curcumin or a placebo as Study medication

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

1 Male or female subjects between 21 to 45 years of age 2 Subject with BMI range (28-32) 3 Ability to understand the risks/benefits of the protocol 4 Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera Â®, or double-barrier and have a negative pregnancy test at the Screening Visit.
Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy 5 Willingness to participate in a walking-exercise program of 30 minutes of walking per day, in additional to their currently daily activity routine, during the course of the study.
6 Subject agrees to consume a vegetarian/non-vegetarian dietof approximately 1800 kcal/day (17% protein, 25% Fat and 58% carbohydrate).
7 Subject should be available for duration of study period (6-8 months) 8 Subjects agree to come to site in fasting state for their weight measurement and other laboratory parameters examination in all the scheduled visits.
9 Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies during this study.
10 Subject agrees not to start any new therapies for weight loss during the course of the study.
11 Subjects willing to go for DEXA analysis during the course of study.
12 Subjects agree to maintain the activity dairy 13 Willing to give written informed consent and willing to comply with trial protocol.

Exclusion Criteria

1 Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain 2 Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudogout, Pagets disease, joint fracture, acromegaly, fibromyalgia, Wilsons disease, ochronosi, haemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis 3 Subjects having history of asthma 4 Subjects having history of cardiovascular diseases 5 Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose â‰¥ 140-199 mg/dl.
6 Subject with hyperuricemia (males 480 Âµmol/L, females 450 Âµmol/L) 7 Subjects having thyroid disease 8 Subjects having abnormal liver or kidney function test (ALT or AST 2 times the upper limit of normal; elevated creatinine, male 125 Âµmol/L, female 110 Âµmol/L) 9 Subjects having abnormal findings on complete blood count 10 Subjects having history of coagulopathies 11 Subjects with hypertension 12 Subjects with HIV Positive 13 Subjects having history of congestive heart failure 14 Subjects having history high alcohol intake (2 standard drinks per day) 15 Pregnant, breast feeding or planning to become pregnant during the study 16 Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent 17 Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures 18 Subjects participated in any investigational study medication within thirty (30) days prior to screening.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from the baseline to the end of the treatment period in body weight, BMI, Wasit Hip Ratio, Body fat and body composition	Change from the baseline to the end of the treatment period in body weight, BMI, Wasit Hip Ratio, Body fat and body composition

Secondary Outcome Measures

Name	Time	Method
Change from the baseline to the end of the treatment period in LDL, HDL and total cholesterol	Visit-1,4,5 and 7
Change from the baseline to the end of the treatment period in Visual Analog Scale (VAS) and Profile of Mood States-Short Form (POMS-SF) questionnaire.

Trial Locations

Locations (4): Alpha Hospital & Research Centre
🇮🇳
Madurai, TAMIL NADU, India
Karpagam Hospital
🇮🇳
Madurai, TAMIL NADU, India
R.K.HOSPITAL
🇮🇳
Krishna, ANDHRA PRADESH, India
Suraksha Health Village
🇮🇳
Krishna, ANDHRA PRADESH, India
Alpha Hospital & Research Centre
🇮🇳Madurai, TAMIL NADU, India
Dr V Kumaravel
Principal investigator
drvkumaravel@gmail.com