SACHA INCHI (PLUKENETIA VOLUBILIS L.) OIL SUPPLEMENTATION AMONG THE 3HS (HYPERGLYCAEMIA, HYPERTENSION & HYPERLIPIDAEMIA) PATIENTS: A RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLINDED HUMAN CLINICAL TRIAL
Sacha Inchi Oil Supplementation in 3Hs: A randomized, placebo-controlled human clinical trial
General Information
Study Information
Inclusion & Exclusion Criteria
- 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)
This study will exclude individuals who are:
- 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 Cushings-, Addisons-, Graves- and Hashimotos 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.
- 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)
This study will exclude individuals who are:
- 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 Cushings-, Addisons-, Graves- and Hashimotos 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.
Study Timeline