Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256332
• Other study ID #: FDS-NAA-1633
• Status: Completed
• Phase: N/A
• First received: September 30, 2014
• Last updated: September 21, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Research Ethics committee
• Study type: Interventional

Clinical Trial Summary

Effects of a plant based ingredient on blood glucose in Type II diabetes patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Low dose plant based ingredient
Reference food with low dose of plant based ingredient
• High dose plant based ingredient
Reference food with high dose of plant based ingredient
• Reference food format
Reference food without plant-based ingredient

Locations

Country	Name	City	State
India	Lambda Therapeutics Research Ttd (LTRL)	Ahemdabad
India	Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post prandial blood glucose positive incremental area under the curve		180 and 240 minutes	No
Other	Post prandial insulin area under the curve		180 and 240 minutes	No
Other	Glucose levels in urine		240 minutes	No
Other	Intestinal discomfort	Intestinal discomfort will be evaluated by a paper and pen questionnaire in the subject's native language directed to intestinal symptoms (nausea, flatulence, bloating and abdominal pain).	240 minutes	No
Primary	Post prandial blood glucose positive incremental area under the curve		120 minutes	No
Secondary	Post prandial insulin area under the curve		120 minutes	No