Evaluation of blood cholesterol lowering effect of a novel functional fermented betaglucan enriched oat bran/milk based drink.

Active, not recruiting

• Conditions: Hyperlipidemia

• Registration Number: CTRI/2013/12/004189
• Lead Sponsor: Swedish International Development Corporation agency

Brief Summary

This study is a double blind,balanced, randomized, controlled two-way cross over trial to evaluate the blood cholesterol lowering effect of a novelfunctional fermented Betaglucan enriched oat bran/milk based drink administered460 g daily for three months in 38patients with hyperlipidemia that will be conductedin Ahmedabad, India. The primary outcome measures will be parameters such as 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 sensitivityC-reactive protein (hscrp) and Faecal microflora (*Lactobacillus andBifidobacterium spp*) at every 28 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-16
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• 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.
• Having a Body Mass Index (BMI) between 20 and 30 (both inclusive), calculated as weight in kg/height in m2.
• 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).
• Able to understand and comply with the study procedures, in the opinion of the investigator.
• Subject must have a proper storage appliance (i.e. fridge) at home in working condition to store the IFP below 8° C.
• Able to give voluntary written informed consent for participation in the trial.
• Having serum cholesterol ≥ 200 mg/dl.
• Having LDL- cholesterol ≥130 mg/dl.
• 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

• Known hypersensitivity to milk or any content of the Investigational food product.
• 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.
• 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.
• 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.
• Consumption of Grapefruits or its products within a period of 48 hours prior to receiving the first IFP.
• Smokers, or who have smoked within last six months prior to start of the study.
• 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.
• Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
• History or presence of psychiatric disorder xii.
• A history of difficulty with donating blood.
• 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 ≤ 200 mL, subject may be enrolled 60 days after the last sample of previous study.
• A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
• A positive test result for HIV antibody.
• An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the first IFP.
• Nursing mothers (females).
• Having Serum Triglyceride above 354 mg/dl.
• Blood pressure more than 160 mmHg and 95 mmHg for the systolic and diastolic respectively at the time of screening.
• History of presence of Glucosurea xxi.
• A history of presence of coronary heart disease and/or a decompensatio cordis of cardiomyopathy.
• Use of medication known to affect the efficacy parameter measured in the study.
• History of known gluten intolerance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LDL-Cholesterol	28 days

Secondary Outcome Measures

Name	Time	Method
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)	28 days

Trial Locations

Locations (1)

Lambda Therapeutic Research Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

Lambda Therapeutic Research Ltd.

🇮🇳Ahmadabad, GUJARAT, India

Dr Akash Patel MD

Principal investigator

79-40202020

akashpatel@lambda-cro.com