Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes
Information source: Unilever R&D
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: Low dose plant based ingredient (Dietary Supplement); High dose plant based ingredient (Dietary Supplement); Reference food format (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: Unilever R&D Official(s) and/or principal investigator(s): Dr Ketul Modi, MBBS, Principal Investigator, Affiliation: Lambda Therapeutics Research Ltd (LTRL) Dr Shrikant V Deshpande, Principal Investigator, Affiliation: Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
Overall contact: Theo Mulder, PhD, Phone: +31 10 640 8315, Email: theo.mulder@unilever.com
Summary
Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
Clinical Details
Official title: Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Post prandial blood glucose positive incremental area under the curve
Secondary outcome: Post prandial insulin area under the curve
Detailed description:
The study is designed to determine the extend to which a plant based ingredient in a food
format affects blood glucose responses in untreated Type II diabetes patients.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female volunteers with confirmed Type II diabetes not treated with
pharmaceutical-based glucose lowering treatment for past three months (controlled
solely through diet and exercise);
- Age ≥ 20 and ≤ 65 year at screening;
- Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
- HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6. 5% and ≤ 7. 0%). At discretion of the study
physician, subjects with HbA1c >53 mmol/mol and <58 mmol/mol (>7. 0% and < 7. 5%)
controlled solely through diet and exercise are also allowed to participate.
Exclusion Criteria:
- Being an employee of Unilever or research site;
- Chronic smokers, tobacco chewers and drinkers;
- No medication, including vitamins and tonics, except for cholesterol, as determined
by the physician;
- Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
- Allergy to any food or cosmetics;
- If female, not being pregnant or planning pregnancy during the study period;
- If female, lactating or has been lactating for 6 weeks before pre-study investigation
and/or during the study period.
Locations and Contacts
Theo Mulder, PhD, Phone: +31 10 640 8315, Email: theo.mulder@unilever.com
Lambda Therapeutics Research Ttd (LTRL), Ahemdabad, India; Recruiting Dr Ketul Modi, MBBS, Principal Investigator
Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA, Thane, Maharashtra, India; Recruiting Dr Shrikant V Deshpande Dr Shrikant V Deshpande, Principal Investigator
Additional Information
Starting date: January 2015
Last updated: April 30, 2015
|