None listed
Conditions
Interventions
Intervention1: A novel functional fermented beta-glucan enriched oat bran/milk based drink
: Once in three weeks.
Duration is three weeks.
Intervention2: Fermented milk based drink
: Once in three we
Sponsors
Swedish International Development Corporation agency
Eligibility
Inclusion criteria
Inclusion criteria: i. Non-smoking, healthy, adult, human subjects between 18 and 55 years of age (both inclusive) living in and around Ahmedabad city or western part of India. ii. Having a Body Mass Index (BMI) between 25 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. Able to give voluntary written informed consent for participation in the trial. vi. 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 and / or oats 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 (probiotic capsules or probiotic food like Yakult 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 hypoglycaemic drug or any other drug which in opinion of the PI has effect on postprandial effect on blood glucose and insulin levels 14 days prior to receiving the first IFP. v. 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. History of presence of Glucosurea xix. Use of medication known to affect the efficacy parameter measured in the study. xx. History of known gluten intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post prandial capillary blood glucose and serum InsulinTimepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective satiety and hunger data for each study occasion.Timepoint: 3 weeks | — |
Countries
India
Contacts
Public ContactMrJigar Trivedi
Lambda Therapeutic Research Ltd.
Outcome results
None listed