Effect of green algae in healthy adults as source of vitami
- Registration Number
- CTRI/2023/08/056667
- Lead Sponsor
- East India Distilleries Parry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Healthy male/female participants between the age group =18 and = 60 years of age at the time of consent.
Subject must agree not to use any dairy product during the course of this study and obey strictly.
Participants with body mass index between 18.5 and 30kg/m2
Participants having serum vitamin B12 levels =107 pmol/l and =210 pmol/l at the time of screening.
Participants having haemoglobin levels =11 g/dl for women and =12 g/dl for men at the time of screening.
Participants who are willing to comply with the study procedures and restrictions.
Female patients having negative urine pregnancy test at the time of screening.
Patients willing to provide signed informed consent form
Patients having an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal,pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study outcomes.
Participants with pre-existing medically diagnosed diabetes.
Patients consuming vitamin B12 supplements (either signally or in combination with other vitamins and minerals) or have received a vitamin B12 injection in the last 6 months.
Participants who have treatment with drugs which interfere with folate metabolism or interfere with folic acid and vitamin B12 assay.
Patients with the history of or diagnosed with thrombocytopenia, leukopenia, pancytopenia, or any other haematological malignancy.
Participants with a history of recurrent or current abuse of alcohol.
Participants who are non-vegetarians
Pregnant or lactating women.
Females at childbearing age will be excluded unless they are using acceptable birth control measures (i.e., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner) Being a participant in another clinical trial in the last three months and during study participation.
Patient with moderate to severe covid symptoms.
Participant with any other condition, which as per the investigator would jeopardize the outcome of the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum vitamin B12 levelsTimepoint: Baseline to week 12
- Secondary Outcome Measures
Name Time Method Change in Homocysteine, Folic acid, haemoglobin & MMA levelsTimepoint: From baseline to week 12;WHOQOL-BREFTimepoint: From baseline to week 12