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CompletedNCT02218528Updated Feb 18, 2015

Effect of a Plant-based Ingredient on Glucose Response

An interventional study of Plant-based ingredient and No Plant-based ingredient in Healthy, sponsored by Unilever R&D. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-18.

Sponsored by Unilever R&D (part of Unilever) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • subjects
03

In context

Lead sponsor

Unilever R&D is the lead sponsor of 70 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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;
  • If female: pregnant or will be planning pregnancy during the study period;
  • If female: lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
48 participants (actual)

Study arms

  • Placebo comparator
    Starchy meal

    No Plant-based ingredient added to a starchy meal

    Dietary Supplement: No Plant-based ingredient

  • Active comparator
    Low dose added to starchy meal

    Plant-based ingredient in low dose added to starchy meal

    Dietary Supplement: Plant-based ingredient

  • Placebo comparator
    Starchy meal and side dish

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

    Dietary Supplement: No Plant-based ingredient

  • Active comparator
    Low dose added to starchy meal and side dish

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

    Dietary Supplement: Plant-based ingredient

  • Active comparator
    Medium dose added to starchy meal and side dish

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

    Dietary Supplement: Plant-based ingredient

  • Active comparator
    High dose added to starchy meal and side dish

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

    Dietary Supplement: Plant-based ingredient

Interventions

  • Dietary supplementPlant-based ingredient
  • Dietary supplementNo Plant-based ingredient
06

What researchers measure

Primary outcomes

  1. Positive incremental post-prandial blood glucose area unde the curve

    Time frame: 120 minutes

Secondary outcomes

  1. Positive incremental post-prandial blood glucose area under the curve

    Time frame: 180 minutes

  2. Post-prandial insulin response

    Time frame: 120 minutes

  3. Post-prandial insulin response

    Time frame: 180 minutes

  4. Assessment of gastric emptying rate

    GE50% (time to empty 50% of the gastric content) will be determined with paracetamol

    Time frame: 10 hours

Other outcomes

  1. Cmax

    peak plasma glucose

    Time frame: 120 minutes

  2. Cmax-baseline corrected

    peak plasma glucose - baseline plasma glucose

    Time frame: 120 minutes

  3. Tmax

    peak time plasma glucose

    Time frame: 120 minutes

07

Study locations

1 site
  • Lambda Therapeutics Research Ltd (LTRL)
    Ahmedabad, India
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2014, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2014
First posted
Aug 18, 2014
Start
Aug 2014
Primary completionActual
Sep 2014
CompletionActual
Sep 2014
Last update
Feb 18, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02218528
Lead sponsor
Unilever R&D
Responsible party
Sponsor
First posted
Aug 18, 2014
Start date
Aug 2014
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Feb 18, 2015

Study contacts

Dr. Ketul Modi, MBBS
principal investigator · Lambda Therapeutics Research Ltd (LTRL)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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