Health Condition 1: null- Overweight individuals with fatty liver
Conditions
Interventions
Intervention1: Parry Organic spirulina with 20 to 24% phycocyanin: 1g tablet morning and at night for 6 months
Control Intervention1: Spirulina with lower content of phycocyanin and spirulina with hig
Sponsors
Parry Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Volunteers shall meet all of the following inclusion criteria to be eligible for participation in this study: 1.Male and female patients of age greater than 18 and less than 65 years shall be selected. 2.BMI greater than or equal to 25 kg/m2 or Waist circumference for male greater than 90cm & female greater than 80 cm 3.Subjects fasting blood glucose level less than 120mg/dl. 4.Subjects Blood Pressure should be between 110-139/70-89mm hg with or without treatment. 5.Triglyceride greater than 150mg/dl. 6.Ultrasound finding showing fatty liver 7.Adult patients willing to give informed consent. 8.Subject must be available for and willing to attend all evaluation visits. 9.Subject must have access to telephone for calling into the clinical center as part of test product compliance or be willing and able to fill in a daily dairy for clinical review.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1.Patients suffering from Diabetes mellitus 2.Subjects below the age of 18 years and above the age of 65 years 3.Subjects with BMI greater than 25 kg/m2 4.Chronic alcohol intake. 5.History of any drug abuse in the past 12 months. 6.History of hypersensitivity to study medications and related drugs or excipients in the formulation. 7.History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions. 8.History of Congestive Heart Failure 9.History of End Stage Renal Failure 10.Subject with uncontrolled hypertension 11.History of stroke 12.History of myocardial infarction 13.History of Unstable angina pectoris 14.Subjects who are under treatment with Glucocorticoids oestrogens tamoxifen amiodarone methotrexate diltiazem zidovudine valproate aspirintetracycline and cocaine. 15.Patient who is not willing to participate in the study 16.Clinically significant abnormal laboratory results at screening. 17.Subject is being treated for severe active infection of any type 18.A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study 19.Subject with clinically relevant uncontrolled medical condition(e.g. hematologic renal hepatic neurologic cardiac or respiratory) 20.Subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years 21.Participating in a clinical research trial within 30 days prior to randomization 22.Individuals who are cognitively impaired and/or who are unable to give informed consent. 23.Any other health or mental condition that in the Investigatorâ??s opinion may adversely affect the subjectâ??s ability to complete the study or its measures or that may pose significant risk to the subject. The patients meeting any of the above criteria will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in metabolic reactive oxidative stress markers 1.TNFalpha 2.Malondialdehyde 3.serum IL-6 4.AdiponectinTimepoint: baseline 3 months 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of spirulina containing higher phycocyanin in fatty liver volunteersTimepoint: Baseline 3months 6 months | — |
Countries
India
Contacts
Public ContactMrSundarapandi
Parry Nutraceuticals
Outcome results
None listed