NCT02256332

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

September 30, 2014

Last Update Submit

September 21, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Post prandial blood glucose positive incremental area under the curve

    120 minutes

Secondary Outcomes (1)

  • Post prandial insulin area under the curve

    120 minutes

Other Outcomes (4)

  • 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

  • +1 more other outcomes

Study Arms (3)

Low dose plant based ingredient

ACTIVE COMPARATOR

Reference food with low dose of plant based ingredient

Dietary Supplement: Low dose plant based ingredient

High dose plant based ingredient

ACTIVE COMPARATOR

Reference food with high dose of plant based ingredient

Dietary Supplement: High dose plant based ingredient

Reference food format

PLACEBO COMPARATOR

Reference food without plant-based ingredient

Dietary Supplement: Reference food format

Interventions

Low dose plant based ingredientDIETARY_SUPPLEMENT

Reference food with low dose of plant based ingredient

Low dose plant based ingredient
High dose plant based ingredientDIETARY_SUPPLEMENT

Reference food with high dose of plant based ingredient

High dose plant based ingredient
Reference food formatDIETARY_SUPPLEMENT

Reference food without plant-based ingredient

Reference food format

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA

Thane, Maharashtra, India

Location

Lambda Therapeutics Research Ttd (LTRL)

Ahemdabad, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dr Ketul Modi, MBBS

    Lambda Therapeutics Research Ltd (LTRL)

    PRINCIPAL INVESTIGATOR

  • Dr Shrikant V Deshpande

    Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 3, 2014

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

IN(2)