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Omega 3 status in Indian populatio

Not Applicable
Conditions
Health Condition 1: E888- Other specified metabolic disorders
Registration Number
CTRI/2022/12/048407
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Male Female subjects aged 25 to 60 years

Clinically stable for at least 6 months

Capable of giving written informed consent and able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions

Exclusion Criteria

Inability to give consent

Pregnant or breast-feeding.

Evidence of clinical instability or abnormal clinical laboratory findings prior to randomization that, in the opinion of the Investigator, makes the subject unsuitable for the study.

•Exposure to substantial radiation within the past 12 months.

•Planned cardiac surgery (e.g., CABG, valve repair or replacement), PCI or major non-cardiac surgery within the study period.

•Diabetics taking injectable insulin at screening.

•Current life-threatening condition other than vascular disease (e.g., very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study.

•Any other subject the Investigator deems unsuitable for the study (e.g., due to either medical reason, laboratory abnormalities, expected study medication non-compliance, inability to medically tolerate the procedures or subjectâ??s unwillingness to comply with all study-related procedures).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
This study will elucidate light on the circadian activities of key metabolic functions together which is important for the maintenance of metabolic homeostasis. Furthermore, it would be interesting to elucidate Circadian reproducibility and variability of Twenty Four Hours /Seven days Blood Pressure and blood glucose indices in Patients with Metabolic DiseasesTimepoint: the total duration of the study is 2.6 years <br/ ><br>24h 7 days ABPM, including Heart rate variability, AGMS â??Ambulatory Glucose Monitoring, Sleep Activity analysis, metabolic hormones <br/ ><br>It will be measured two times once during the screening study once after six months of supplementation <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
This study will elucidate light on circadian activities of key metabolic function together which is important for the maintenance of metabolic homeostasis. Furthermore, it would be interesting to elucidate Circadian reproducibility and variability of Twenty Four Hours /Seven days Blood Pressure and blood glucose indices in Patients with Metabolic DiseasesTimepoint: the total duration of the study is 2.6 years <br/ ><br>24h 7 days ABPM, including Heart rate variability, AGMS Ambulatory Glucose Monitoring, Sleep Activity analysis, metabolic hormones <br/ ><br>It will be measured two times once during the screening study once after six months of supplementation <br/ ><br>
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