NCT02218528

Brief Summary

The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

August 1, 2014

Enrollment Period

1 month

First QC Date

August 14, 2014

Last Update Submit

February 17, 2015

Conditions

Healthy

Keywords

subjects

Outcome Measures

Primary Outcomes (1)

  • Positive incremental post-prandial blood glucose area unde the curve

    120 minutes

Secondary Outcomes (4)

  • Positive incremental post-prandial blood glucose area under the curve

    180 minutes

  • Post-prandial insulin response

    120 minutes

  • Post-prandial insulin response

    180 minutes

  • Assessment of gastric emptying rate

    10 hours

Other Outcomes (3)

  • Cmax

    120 minutes

  • Cmax-baseline corrected

    120 minutes

  • Tmax

    120 minutes

Study Arms (6)

Starchy meal

PLACEBO COMPARATOR

No Plant-based ingredient added to a starchy meal

Dietary Supplement: No Plant-based ingredient

Low dose added to starchy meal

ACTIVE COMPARATOR

Plant-based ingredient in low dose added to starchy meal

Dietary Supplement: Plant-based ingredient

Starchy meal and side dish

PLACEBO COMPARATOR

No Plant-based ingredient added to starchy meal and side dish

Dietary Supplement: No Plant-based ingredient

Low dose added to starchy meal and side dish

ACTIVE COMPARATOR

Plant-based ingredient in low dose added to starchy meal and side dish

Dietary Supplement: Plant-based ingredient

Medium dose added to starchy meal and side dish

ACTIVE COMPARATOR

Plant-based ingredient in medium dose added to starchy meal and side dish

Dietary Supplement: Plant-based ingredient

High dose added to starchy meal and side dish

ACTIVE COMPARATOR

Plant-based ingredient in high dose added to starchy meal and side dish

Dietary Supplement: Plant-based ingredient

Interventions

Plant-based ingredientDIETARY_SUPPLEMENT
High dose added to starchy meal and side dishLow dose added to starchy mealLow dose added to starchy meal and side dishMedium dose added to starchy meal and side dish
No Plant-based ingredientDIETARY_SUPPLEMENT
Starchy mealStarchy meal and side dish

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;
  • Apparently healthy: no medical conditions which might affect the study measurements, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
  • Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
  • Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm/dL; both inclusive) as judged by the research physician;
  • Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;
  • Agreeing to be informed about medically relevant personal test-results by study physician;
  • Willing to comply to study protocol during study;
  • Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
  • Accessible veins on arms as determined by examination at screening;
  • Being literate;
  • HbA1C ≤ 6.5 % (48 mmol/mol).

You may not qualify if:

  • Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
  • Any history of gastro-intestinal disorders (including frequent diarrhoea for example);
  • Blood donation in the past 2 months;
  • Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
  • Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between 23.00 PM and 6.00 AM;
  • Reported intense sporting activities \> 10h/w;
  • Consumption of ≥120 ml of alcoholic drinks for males and females in a typical week;
  • Drug abuse as indicated by urine analysis;
  • Chronic smokers, tobacco chewers and drinkers;
  • Use of any medication, including supplements and traditional medicine;
  • Reported dietary habits, such as a medically prescribed/slimming diet;
  • Not being used to eat breakfast;
  • Reported weight loss/gain (\>10%) in the last six month before the study;
  • Being an employee of Unilever or CRO;
  • Allergy or intolerance to food products and aversion to food products provided during the study;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lambda Therapeutics Research Ltd (LTRL)

Ahmedabad, India

Location

Study Officials

  • Dr. Ketul Modi, MBBS

    Lambda Therapeutics Research Ltd (LTRL)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 18, 2015

Record last verified: 2014-08

Locations

IN(1)