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

Blood Glucose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256746
• Other study ID #: FDS-NAA-0720
• Status: Completed
• Phase: N/A
• Start date: September 24, 2012
• Est. completion date: October 19, 2012

Study information

• Verified date: February 2020
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 19, 2012
• Est. primary completion date: October 19, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Glucose

Intervention

Other:
• Boiled Rice

• Boiled Rice+0.37 gr mulberry fruit powdered extract

• Boiled Rice+0.75 gr mulberry fruit powdered extract

• Boiled Rice+1.12 gr mulberry fruit powdered extract

• Boiled Rice+1.50 gr mulberry fruit powdered extract

• Rice Porridge

• Rice porridge+1.50 gr mulberry fruit powdered extract

Locations

Country	Name	City	State
India	Lambda Therapeutics Research Ttd (LTRL)	Ahmedabad	Gujarat

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Lambda Therapeutic Research Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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