Status:
COMPLETED
Sacha Inchi Oil Supplementation in 3Hs
Lead Sponsor:
Universiti Sains Malaysia
Conditions:
Endocrine and Metabolic Secondary Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the effect of Sacha Inchi Oil supplementation among the 3Hs patients.
Detailed Description
Non-communicable diseases (NCDs) are the leading cause of death worldwide. In Malaysia, NCDs account for 67% of premature mortality, and over 70% of disease burden in 2014. In 2016, NCDs were responsi...
Eligibility Criteria
Inclusion
- Clinically diagnosed with 3 simultaneous NCDs (T2DM, hypertension and hyperlipidaemia), for at least 6 months' duration, sub-optimally controlled without clinically manifest complications (retinopathy, diabetic nephropathy, foot ulcer, cardiovascular diseases, chronic kidney disease, aneurysms).
- Male or female
- Pharmacological treated with oral anti-diabetic agents (metformin, sulphonylureas, meglitinides, alpha-glucosidase inhibitors, Thiazolidinediones, Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, or Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors) and/or injecting agents (Glucagon-like Peptide-1 (GLP-1) Receptor Agonists, anti-hypertensive agents (diuretics, beta blockers, calcium channel blockers, ACE inhibitors, angiotensin inhibitor blockers and direct renin inhibitors) and lipid modifying agents (statins, fibrates, PCSK 9 inhibitors, anion exchange resins, niacin and cholesterol absorption inhibitors) as standard medication regimen.
- Chronological age of 18 years and above
- Metabolically stable with baseline biochemical screening taken at least one (1) month before intervention. Values as below:
- A1c 6.0-8.5%; fasting plasma glucose 6.4-8.5mmol
- Blood pressure \>140/90mmHg - ≤180/110mmHg
- Total cholesterol (TC) \>5.2 mmol/L; high density lipoprotein cholesterol (HDL-C) \<1.0 mmol/L (males), \<1.2 mmol/L (females); triglycerides (TG) \> 1.7 mmol/L, low density lipoprotein cholesterol (LDL-C) \>3.4 mmol/L
- Not taking anti-inflammatory supplements (example of the anti-inflammatory supplement: fish oil, flaxseed oil, curcumin extract, ginger extract, spirulina, vitamin C, polyphenol extract blend)
Exclusion
- Have been diagnosed with liver diseases (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders based on pre-screening medical records and during face-to-face interview prior to recruiting. Subjects with identified non-alcoholic steatohepatitis will be excluded through initial AMDI database screening based on liver enzymes blood routine check.
- Active gastric/duodenal ulcer
- Psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia)
- Cancer (all types), and other diagnosed endocrine disorders apart from type 2 DM such as Cushing's-, Addison's-, Grave's- and Hashimoto's disease, gigantism, acromegaly, hyper- and hypothyroidism.
- Alcohol and drug abuse (self-mentioned or as recorded in the medical card)
- Gestational diabetes mellitus
- Pregnant/lactating. Pregnancy screening test will be conducted for all childbearing age women.
- Hormone replacement therapy (for at least 3 months before entering the study)
- Using herbal remedies (any parts from the plants such as flower, rhizome, seeds, roots, leaves, fruits, stems). Herbal remedies used are medicinal products consisting of a concoction of various plants, used, and believed as disease management and prevention is excluded. Meanwhile ulam (traditional Malay salad) is defined as fresh or raw green salad that can be eaten with fermented sauce, herbs, or spices as side dishes . Ulam consumers will be recruited in the study as ulam is considered as salad consumption.
- Use of steroids, chemotherapy, immunosuppressants or radiotherapy
- Currently under another supplementary program. Other supplementary programmes are defined as a person is enrolled in another clinical trial with the intention-to-treat drugs/supplements. Vitamins or any other supplements (e.g: iron) is included if the outcome is to see to the effect of disease management or prevention.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04920825
Start Date
May 1 2021
End Date
December 31 2022
Last Update
January 11 2023
Active Locations (1)
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1
Advanced Medical and Dental Institute (AMDI)
Kepala Batas, Pulau Pinang, Malaysia, 13200