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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

Page last updated: August 23, 2015

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