Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2023
INTERVENTION: A randomized, placebo‐controlled, prospective clinical trial was conducted at the Institute of Medical Research (MRI), Colombo, Sri Lanka. Participants were recruited from a local advertisement displayed in the Medical Research Institute, Colombo, Sri Lanka. A comprehensive medical history was obtained, and a physical examination of the subjects who volunteered was done before recruiting. A random number between 1 and 4, taken from a table of random numbers, was assigned to each consented participant. The participants were randomly allocated to one of three dietary supplementation regimens: coconut milk powder 30 g, grated coconut 30 g or coconut oil 30 ml, or the control group. The coconut supplements were not equi‐caloric and had different fat, fiber, and protein content. Each participant was instructed to take the allocated supplement for 4 weeks and was asked to maintain a daily dietary diary to ensure that the diet did not vary significantly. Fasting Blood Sugar (FBS) and HbA1c were measured three times: i.e., baseline, after 4 weeks and 8 weeks. BMI was measured by a single research assistant and all laboratory tests were done by a single technician. Lipid profiles were done after 10 hours of mandatory fasting and FBS was done after 8 hours fast. Total cholesterol, HDL‐cholesterol and triglyceride concentrations were measured in serum by a Roch/Hitachi Modular P Chemistry Analyzer (Mod P). The cholesterol assay used the cholesterol oxidase/peroxidase (CHOD/POD) method. HDL cholesterol was measured by a direct non‐precipitating method using polyethylene glycol‐coupled cholesteryl esterase (PEG‐modified enzyme) and cholesterol oxidase. Triglycerides were analyzed using the glycerokinase/glycerophosphate oxidase method after initial hydrolysis with lipoprotein lipas CONDITION: Lipid profile ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: 1. Lipid profile (consisting of total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride concentrations) measured at baseline and after 4 and 8 weeks. Lipid profiles were done after 10 hours of mandatory fasting and FBS was done after 8 hours fast.; 1.1. Total cholesterol, HDL‐cholesterol and triglyceride concentrations measured in serum by a Roch/Hitachi Modular P Chemistry Analyzer (Mod P); 1.2. The cholesterol assay used the cholesterol oxidase/peroxidase (CHOD/POD) method; 1.3. HDL cholesterol was measured by a direct non‐precipitating method using polyethylene glycol‐coupled cholesteryl esterase (PEG‐modified enzyme) and cholesterol oxidase; 1.4. Triglycerides were analyzed using the glycerokinase/glycerophosphate oxidase method after initial hydrolysis with lipoprotein lipase. LDL cholesterol was calculated using the Friedewald formula. SECONDARY OUTCOME: Fasting blood sugar (FBS) and HbA1c measured using Abbott’s Diabetes Care FreeStyle Libre at baseline, after 4 weeks and 8 weeks INCLUSION CRITERIA: 1. Healthy volunteers aged 25‐60 years 2. Total cholesterol level =250 mg/dl 3. Triglyceride level =300 mg/dl 4. Not on any form of medication or on nutritional supplementation
Epistemonikos ID: 79abbe7432fbd56a1559de04e26eab9c6cf43b09
First added on: Aug 26, 2024