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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Low dose plant based ingredient; Dietary supplement: High dose plant based ingredient; Dietary supplement: Reference food format

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Ahemdabad, India
    • Lambda Therapeutics Research Ttd (LTRL)
  • Maharashtra
    • Thane, Maharashtra, India
      • Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low dose plant based ingredient; Reference food with low dose of plant based ingredient	Dietary supplement: Low dose plant based ingredient; Reference food with low dose of plant based ingredient
Active Comparator: High dose plant based ingredient; Reference food with high dose of plant based ingredient	Dietary supplement: High dose plant based ingredient; Reference food with high dose of plant based ingredient
Placebo Comparator: Reference food format; Reference food without plant-based ingredient	Dietary supplement: Reference food format; Reference food without plant-based ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post prandial blood glucose positive incremental area under the curve	120 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Post prandial insulin area under the curve	120 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post prandial blood glucose positive incremental area under the curve		180 and 240 minutes
Post prandial insulin area under the curve		180 and 240 minutes
Glucose levels in urine		240 minutes
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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Investigators: Principal Investigator: Dr Ketul Modi, MBBS, Lambda Therapeutics Research Ltd (LTRL); Principal Investigator: Dr Shrikant V Deshpande, Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 3, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: FDS-NAA-1633