Back to resultsPlant-based Ingredient on Post Prandial Glucose in Type II Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Low dose plant based ingredient
High dose plant based ingredient
Reference food format
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility 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.
Sites / Locations
- Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
- Lambda Therapeutics Research Ttd (LTRL)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Low dose plant based ingredient
High dose plant based ingredient
Reference food format
Arm Description
Reference food with low dose of plant based ingredient
Reference food with high dose of plant based ingredient
Reference food without plant-based ingredient
Outcomes
Primary Outcome Measures
Post prandial blood glucose positive incremental area under the curve
Secondary Outcome Measures
Post prandial insulin area under the curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02256332
Brief Title
Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes
Official Title
Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose plant based ingredient
Arm Type
Active Comparator
Arm Description
Reference food with low dose of plant based ingredient
Arm Title
High dose plant based ingredient
Arm Type
Active Comparator
Arm Description
Reference food with high dose of plant based ingredient
Arm Title
Reference food format
Arm Type
Placebo Comparator
Arm Description
Reference food without plant-based ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
Low dose plant based ingredient
Intervention Description
Reference food with low dose of plant based ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
High dose plant based ingredient
Intervention Description
Reference food with high dose of plant based ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
Reference food format
Intervention Description
Reference food without plant-based ingredient
Primary Outcome Measure Information:
Title
Post prandial blood glucose positive incremental area under the curve
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Post prandial insulin area under the curve
Time Frame
120 minutes
Other Pre-specified Outcome Measures:
Title
Post prandial blood glucose positive incremental area under the curve
Time Frame
180 and 240 minutes
Title
Post prandial insulin area under the curve
Time Frame
180 and 240 minutes
Title
Glucose levels in urine
Time Frame
240 minutes
Title
Intestinal discomfort
Description
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).
Time Frame
240 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ketul Modi, MBBS
Organizational Affiliation
Lambda Therapeutics Research Ltd (LTRL)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Shrikant V Deshpande
Organizational Affiliation
Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
City
Thane
State/Province
Maharashtra
Country
India
Facility Name
Lambda Therapeutics Research Ttd (LTRL)
City
Ahemdabad
Country
India
12. IPD Sharing Statement
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Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes
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