Post-prandial Glucose in Healthy Subjects

NCT01955447 | Completed

• 1 other identifier: FDS-NAA-1335
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to determine the extent to which foods containing different levels of plant-based ingredients affect blood glucose responses in healthy subjects.

Conditions

Healthy Subjects

Keywords

Blood glucose

Outcome Measures

Primary Outcomes (1)

• 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

PLACEBO COMPARATOR

no added plant-based ingredients

Dietary Supplement: no added plant-based ingredients to starchy meal

Low level plant-based ingredients

ACTIVE COMPARATOR

Low level addition of plant-based ingredients

Dietary Supplement: Low level plant-based ingredients added to starchy meal

Medium level plant-based ingredients

ACTIVE COMPARATOR

Medium level addition of plant-based ingredients

Dietary Supplement: Medium level plant-based ingredients added to starchy meal

High level plant-based ingredients

ACTIVE COMPARATOR

High level addition of plant-based ingredients

Dietary Supplement: High level plant-based ingredients added to starchy meal

Interventions

no added plant-based ingredients to starchy meal DIETARY_SUPPLEMENT

no added plant-based ingredients to starchy meal

Reference

Low level plant-based ingredients added to starchy meal DIETARY_SUPPLEMENT

Low level plant-based ingredients added to starchy meal

Low level plant-based ingredients

Medium level plant-based ingredients added to starchy meal DIETARY_SUPPLEMENT

Medium level plant-based ingredients added to starchy meal

Medium level plant-based ingredients

High level plant-based ingredients added to starchy meal DIETARY_SUPPLEMENT

High level plant-based ingredients added to starchy meal

High level plant-based ingredients

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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) as judged by the research physician.

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.

Sponsors & Collaborators

• Unilever R&D: lead

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: 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 27, 2013
• First Posted: October 7, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Last Updated: January 22, 2014

Record last verified: 2013-11

Locations

IN (1)