NCT01999543

Brief Summary

The study is designed to determine the extent to which a plant-based ingredient on different food formats affect blood glucose responses in healthy subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

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

November 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

3 months

First QC Date

November 25, 2013

Last Update Submit

February 21, 2014

Conditions

Healthy Subjects

Keywords

Blood glucose

Outcome Measures

Primary Outcomes (1)

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

    120 minutes

Secondary Outcomes (1)

  • Post-prandial insulin area under the curve

    120 minutes

Study Arms (4)

Reference food format

OTHER

reference food format with and without plant-based ingredient added

Dietary Supplement: plant-based dietary supplementOther: Placebo

Food format one

EXPERIMENTAL

Food format one with and without plant-based ingredient added

Dietary Supplement: plant-based dietary supplementOther: Placebo

Food format two

EXPERIMENTAL

Food format two with and without plant-based ingredient added

Dietary Supplement: plant-based dietary supplementOther: Placebo

Food format three

EXPERIMENTAL

Food format three with and without plant-based ingredient added

Dietary Supplement: plant-based dietary supplementOther: Placebo

Interventions

plant-based dietary supplementDIETARY_SUPPLEMENT
Food format oneFood format threeFood format twoReference food format
PlaceboOTHER
Food format oneFood format threeFood format twoReference food format

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing to give consent to participate in the study in writing;
  • Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
  • Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
  • Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
  • Willing to comply to study protocol during the study;
  • Agreeing to be informed about medically relevant personal test-results by study physician;
  • Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
  • Fasting blood glucose value of volunteer 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)

You may not qualify if:

  • Being an employee of Unilever or CRO;
  • Chronic smokers, tobacco chewers and drinkers;
  • Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
  • Use of medication which interferes with study measurements including vitamins, tonics;
  • Reported intense exercise ≥10 h/week;
  • Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
  • Blood donation for 2 months prior to screening;
  • Urine analysis that showed any drug abuse;
  • 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 (1)

Lambda Therapeutics Research Ltd (LTRL)

Ahemdabad, 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
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

November 25, 2013

First Posted

December 3, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations

IN(1)