None listed
Conditions
Interventions
Intervention1: Tart cherry: Dose:500mg Dosage: Capsules
Duration : Period I 28 Days Washout period for 28 days
Period II 28 days.
Control Intervention1: Placebo: Dose:500mg Dosage: Capsules Duration
Sponsors
SPECNOVA LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject must be healthy human male and female (non-pregnant) subjects. 2.Subject with BMI more than 25 -30 kg/m2. 3.Subject should be between 18-45 years of age (both inclusive). 4.Subject who are ready to provide written informed consent and should willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol. 5. Subject with no evidence of underlying disease during the pre-study screening. They must be healthy as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 7 days prior to the commencement of the study. 6.Subject whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
Exclusion criteria
Exclusion criteria: 1.Subjects who are allergic to tart cherry products or any food or other drugs. 2.Subjects who had taken drugs to reduce fat or statins or vitamin supplements (including vitamin E) during the last month. 3.Subjects who are diabetic. 4.Subjects with unresolved infections. 5.Subjects with diseases (cardiovascular disease, inflammatory bowel disease, cancer, or liver disease). 6.Subjects who are smokers. 7.Subject with a history of medication and dietary supplement. 8.Subjects taking anti-inflammatory or lipid-lowering medications. 9.Subject with resting hypotension (BP 140 /90) and pulse rate below 50/min and more than 100/min. 10.Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing. 11.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage. 12.Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study. 13.Subject who has a history of alcoholism, drug abuse or Smoking. 14.Subjects who are hypersensitive to Heparin 15.Subjects who participated in any other clinical study in the past three months. 16.Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X-ray (PA View). 17.Subject who has difficulty with donating blood. 18.Subject with history of difficulty in swallowing. 19.Subject who has unsuitable veins for repeated venipuncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the changes in biomarkers viz., CRP, Plasma urate/uricTimepoint: Period I Visit 1: Day 0 Visit 2: Day 1 Visit 3: Day28 Blood Sampling Point:0min, 120min, 240min, 480min, and 8 hr. Washout period for 28 days Period II Visit 4: Day 57 Visit 5: Day 58 Visit 6: Day 87 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single dose of Tart cherry extract formulations by reviewing adverse events.Timepoint: Period I Visit 1: Day 0 Visit 2: Day 1 Visit 3: Day28 Washout period for 28 days Period II Visit 4: Day 57 Visit 5: Day 58 Visit 6: Day 87 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt. Ltd
Outcome results
None listed