Bioavailability study of Curcuminoid and Lutein combination in healthy subjects

Completed

Brief Summary: The studyconducting in healthy human male subjects to find out Curcuminoidand Lutein combination bioavailability in the body

Curcumin is the principal curcuminoid of the popular Indian spiceturmeric (Curcuma longa), which is an rhizomatous herbaceous perennial plant ofZingiberaceae family which is native to tropical South Asia.

Marigold flower (Tageteserecta L.) represents a rich source of lutein. It is grown for businesspurposes in Mexico, Peru, Ecuador, Spain, India or China. Dried Marigoldflowers contain 0.1â€“0.2% dry matter (DM) of carotenoids, out of which 80% arelutein diesters. By the extraction of dried and ground ï¬‚owers, a non-polaroleoresin extract is acquired

Recruitment & Eligibility

Inclusion Criteria

1.Subjects must be healthy human male subjects.
2.Age should be between 18-65 years of age (both inclusive), weighing at least 50 kg.
3.Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol.
4.Subjects with no evidence of underlying disease during the pre-study screening 5.
They must be healthy as determined by medical history and physical examination and laboratory tests performed within 14 days prior to the commencement of the study.
6.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.

Exclusion Criteria

1.Subjects who are allergic to turmeric or its extracts or curcuminoids or lutein or any food or other drugs.
2.Subject with resting hypotension (BP <90 /60) or hypertension (BP > 140 /90) and pulse rate below 50/min and more than 100/min.
3.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.
4.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
5.Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
6.Subject who have a History of alcoholism, drug abuse or Smoking.
7.Subjects who are hypersensitive to Heparin 8.Subjects who participated in any other clinical study in the past three months.
9.Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X-ray (PA View).
10.Subject who has difficulty with donating blood.
11.Subject with history of difficulty in swallowing.
12.Subject who has unsuitable veins for repeated venipuncture.

Primary Outcome Measures

Name	Time	Method
To determine the bioavailability of curcuminoids and lutein in respective Curcuminoid and Lutein combination based formulations	0:00 min, 30 min, 1, 2, 3, 4, 6 and 24hrs.

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this study is to monitor the safety and tolerability of a single dose of Curcuminoid and Lutein combination formulations in healthy human adult male subjects, under fasting conditions.	0 hr to 24 hrs

Locations (1): Shettys Hospital
🇮🇳
Bangalore, KARNATAKA, India
Shettys Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Amaranth Reddy
Principal investigator
08040943039
dramarclinicblr@gmail.com