Dose Response Study of a Natural Extract for Reducing Post Prandial Blood Glucose

A Natural Extract for Reducing the Post Prandial Blood Glucose Response in Healthy Indian Adults: A Dose-response Study of Efficacy and Tolerance

Randomized, balanced incomplete block design dose response study of efficacy, with 4 different dosages of mulberry fruit powdered extract added to cooked rice compared to a reference treatment (cooked rice only).

Study Overview

• Status: Completed
• Conditions: Blood Glucose
• Intervention / Treatment: Other: Boiled Rice; Other: Boiled Rice+0.37 gr mulberry fruit powdered extract; Other: Boiled Rice+0.75 gr mulberry fruit powdered extract; Other: Boiled Rice+1.12 gr mulberry fruit powdered extract; Other: Boiled Rice+1.50 gr mulberry fruit powdered extract; Other: Rice Porridge; Other: Rice porridge+1.50 gr mulberry fruit powdered extract

Detailed Description

Dose response study with 4 dosages of mulberry fruit powdered extract (0.37, 0.75, 1.12 and 1.5 g) added to cooked rice, compared to cooked rice only(reference) on post prandial blood glucose response in healthy Indian adults.

In addition, 1.5 g of mulberry fruit powdered extract was added to instant rice porridge and compared to instant rice porridge only as positive control (replication of previous research.

In total there were 7 test products in the study: 5 active treatments and 2 reference treatments.

The study was a cross-over study (4 interventions per subject, 4 out of the 7 test products). The recovery period between treatments was at least seven days.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 382481
      • Lambda Therapeutics Research Ttd (LTRL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willing to give consent to participate in the study in writing;
• Healthy male and female subjects between ≥ 20 and ≤ 50.0 years of age;
• BMI of ≥18.0 and ≤ 25.0 kg/m2;
• Apparently healthy: no medical conditions which might effect study measurements as judged by the study physician or measured by questionnaire, and/or assessed by hematology, 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.

Exclusion Criteria:

• Being an employee of Unilever of Lambda;
• 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;
• High intake of alcohol (>120 mL/week);
• Reported use of medically prescribed/slimming diet;
• Reported participation in night shifts (between 23.00 and 6.00 hrs);
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Boiled Rice; 63 g of raw rice was cooked.	Other: Boiled Rice
Experimental: Boiled Rice+0.37 gr extract; 63 g of raw rice was cooked and 0.37 gr mulberry fruit powdered extract added and mixed	Other: Boiled Rice+0.37 gr mulberry fruit powdered extract
Experimental: Boiled Rice+0.75 gr extract; 63 g of raw rice was cooked and 0.75 gr mulberry fruit powdered extract added and mixed	Other: Boiled Rice+0.75 gr mulberry fruit powdered extract
Experimental: Boiled Rice+1.12 gr extract; 63 g of raw rice was cooked and 1.12 gr mulberry fruit powdered extract added and mixed	Other: Boiled Rice+1.12 gr mulberry fruit powdered extract
Experimental: Boiled Rice+1.50 gr extract; 63 g of raw rice was cooked and 1.50 gr mulberry fruit powdered extract added and mixed	Other: Boiled Rice+1.50 gr mulberry fruit powdered extract
Placebo Comparator: Rice porridge; 60 g of rice porridge was rehydrated with 300 ml boiling hot water	Other: Rice Porridge
Active Comparator: Rice porridge+1.50 gr extract; 60 g of rice porridge was rehydrated with 300 ml boiling hot water and 1.50 gr mulberry fruit powdered extract added and mixed	Other: Rice porridge+1.50 gr mulberry fruit powdered extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial blood glucose	Glucose concentration in venous plasma	Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours after test product intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial insulin	Post-prandial serum insulin	Total area under the insulin versus time curves between 0 (before) and 2 hours after study product intake

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydrogen gas in exhaled breath	Each time a volunteer produced a 10 ppm hydrogen (or more) above the basal breath hydrogen level during the 7-hour test period, the value was regarded as a "positive".	Analyzed before study product administration at 20 minutes before and at 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the study products
Intestinal discomfort	A questionnaire to assess four aspects of intestinal discomfort (bloating, flatulence, nausea and pain) on scale from 0-3 was completed by the subjects	Just before and at 430 minutes after study product administration

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Lambda Therapeutic Research Ltd.
• Investigators: Study Director: David Mela, Dr., Unilever R&D Vlaardingen (retired)

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2012
• Primary Completion (Actual): October 19, 2012
• Study Completion (Actual): October 19, 2012

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: FDS-NAA-0720

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No