Health Condition 1: E888- Other specified metabolic disorders
Conditions
Interventions
Intervention1: Flaxseed and palmolien: Blend of High ALA Food Grade Flaxseed Oil and Gold Standard Palmolian oil with Flavoring agent For 6 Month period
Control Intervention1: Mustard oil: For Control
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
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
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 subject’s unwillingness to comply with all study-related procedures).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 24h 7 days ABPM, including Heart rate variability, AGMS –Ambulatory Glucose Monitoring, Sleep Activity analysis, metabolic hormones It will be measured two times once during the screening study once after six months of supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 24h 7 days ABPM, including Heart rate variability, AGMS Ambulatory Glucose Monitoring, Sleep Activity analysis, metabolic hormones It will be measured two times once during the screening study once after six months of supplementation | — |
Countries
India
Contacts
Public Contactkshitij Bhardwaj
King Georges medical university
Outcome results
None listed