A double blind clinical Study to Evaluate Efficacy and Safety of a Novel Enoki Mushroom (Flammulina Velutipes Sing, Chitoglucan Extract) on Weight Management in Healthy Volunteers
- Registration Number
- CTRI/2012/10/003064
- Lead Sponsor
- Iovate Health Sciences International Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1 Male or female subjects between 21 to 45 years of age.
2 Subject with BMI range (26-32).
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 ®, 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 (5 days a week, 30 min per day) with the scheduled timing per week during the course of the study
6 Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 2,000 kcal/day (17% protein, 25% Fat and 58% carbohydrate)
Subject should be available for duration of study period (6-8 months)
7 Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies during this study
8 Subject agrees not to start any new therapies for weight loss during the course of the study
9 Subjects agree to maintain the activity dairy
10 Willing to give written informed consent and willing to comply with trial protocol
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 >= 140-199 mg/dl.
6 Subject with hyperuricemia (males 480 µmol/L, females 450 µmol/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 µmol/L, female 110 µmol/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 RatioTimepoint: Day 0 Day 15 Day 30 Day 60 Day 90 and Day 120
- Secondary Outcome Measures
Name Time Method Change from the baseline to the end of the treatment period in LDL, HDL, VLDL, triglycerides, total cholesterolTimepoint: Day 0 Day 30 Day 60 and Day 120;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. <br/ ><br>Body-fat composition analysis by DEXATimepoint: Day 0, Day 60 and Day 120