None listed
Conditions
Interventions
Intervention1: Test treatment -T: A Novel Functional Fermented Betaglucan Enriched Oat Bran/Milk Based Drink - 230 gm Twice daily for 28 days
Control Intervention1: Control treatment -R: Fermented mil
Sponsors
Swedish International Development Corporation agency
Eligibility
Inclusion criteria
Inclusion criteria: i. Non-smoking, hyperlipidemic, adult, human subjects between 18 and 70 years of age (both inclusive) living in and around Ahmedabad city or western part of India. ii. Having a Body Mass Index (BMI) between 20 and 30 (both inclusive), calculated as weight in kg/height in m2. iii. Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (postero-anterior view). iv. Able to understand and comply with the study procedures, in the opinion of the investigator. v. Subject must have a proper storage appliance (i.e. fridge) at home in working condition to store the IFP below 8° C. vi. Able to give voluntary written informed consent for participation in the trial. vii. Having serum cholesterol >= 200 mg/dl. viii. Having LDL- cholesterol >=130 mg/dl. ix. In case of female subjects: • Surgically sterilized at least 6 months prior to study participation; Or • If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. And • Pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: i. Known hypersensitivity to milk or any content of the Investigational food product. ii. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. iii. Ingestion or Use of any medication (including herbal remedies) at any time in 14 days prior to first IFP administration. In any such case subject selection will be at the discretion of the Principal Investigator. iv. Ingestion of anti-hyperlipidemic drug, plant sterol/stanols in the form of cholesterol lowering margarines type spreads or drinks (i.e Benecol, Becel or similar), diuretics or β-blockers or any other drug which in opinion of the PI has effect on lipid profile 14 days prior to receiving the first IFPv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria. vi. Consumption of Grapefruits or its products within a period of 48 hours prior to receiving the first IFP. vii. Smokers, or who have smoked within last six months prior to start of the study. viii. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving first dose of investigational food product ix. The presence of clinically significant abnormal laboratory values during screening. x. Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans. xi. History or presence of psychiatric disorder xii. A history of difficulty with donating blood. xiii. Donation of blood (1 unit or 350 mL) or receipt of an investigational product or participation in a drug research study within 90 days prior to baseline day. Note: If subject had participated in a study in which blood loss was xiv. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. xv. A positive test result for HIV antibody. xvi. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the first IFP. In any such case subject selection will be at the discretion of the Principal Investigator. xvii. Nursing mothers (females). xviii. Having Serum Triglyceride above 354 mg/dl. xix. Blood pressure more than 160 mmHg and 95 mmHg for the systolic and diastolic respectively at the time of screening. xx. History of presence of Glucosurea xxi. A history of presence of coronary heart disease and/or a decompensatio cordis of cardiomyopathy. xxii. History of serious malignancy and/or drug treatment for hyperlipidemia less than 05 year ago prior to the first IFP. xxiii. Use of medication known to affect the efficacy parameter measured in the study. xxiv. History of known gluten intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-CholesterolTimepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Cholesterol, HDL- Cholesterol, Plasma Fasting Glucose, Triglyceride, Apoliprotein A1 and B, LDL-C/HDL-C ratio, Apo B/Apo A1 ratio, glycosylated haemoglobin (HbA1C), High sensitivity C-reactive protein (hsCRP), Faecal microflora (Lactobacillus and Bifidobacterium spp)Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr J B Prajapati
Lambda Therapeutic Research Ltd.
Outcome results
None listed