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

NCT ID: NCT04256746

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-24
• Study Completion Date: 2012-10-19

Brief 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).

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.

Conditions

Blood Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Boiled Rice

63 g of raw rice was cooked.

Group Type: PLACEBO_COMPARATOR

Boiled Rice

Intervention Type: OTHER

Boiled Rice+0.37 gr extract

63 g of raw rice was cooked and 0.37 gr mulberry fruit powdered extract added and mixed

Group Type: EXPERIMENTAL

Boiled Rice+0.37 gr mulberry fruit powdered extract

Intervention Type: OTHER

Boiled Rice+0.75 gr extract

63 g of raw rice was cooked and 0.75 gr mulberry fruit powdered extract added and mixed

Group Type: EXPERIMENTAL

Boiled Rice+0.75 gr mulberry fruit powdered extract

Intervention Type: OTHER

Boiled Rice+1.12 gr extract

63 g of raw rice was cooked and 1.12 gr mulberry fruit powdered extract added and mixed

Group Type: EXPERIMENTAL

Boiled Rice+1.12 gr mulberry fruit powdered extract

Intervention Type: OTHER

Boiled Rice+1.50 gr extract

63 g of raw rice was cooked and 1.50 gr mulberry fruit powdered extract added and mixed

Group Type: EXPERIMENTAL

Boiled Rice+1.50 gr mulberry fruit powdered extract

Intervention Type: OTHER

Rice porridge

60 g of rice porridge was rehydrated with 300 ml boiling hot water

Group Type: PLACEBO_COMPARATOR

Rice Porridge

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

Rice porridge+1.50 gr mulberry fruit powdered extract

Intervention Type: OTHER

Interventions

Boiled Rice

Intervention Type: OTHER

Boiled Rice+0.37 gr mulberry fruit powdered extract

Intervention Type: OTHER

Boiled Rice+0.75 gr mulberry fruit powdered extract

Intervention Type: OTHER

Boiled Rice+1.12 gr mulberry fruit powdered extract

Intervention Type: OTHER

Boiled Rice+1.50 gr mulberry fruit powdered extract

Intervention Type: OTHER

Rice Porridge

Intervention Type: OTHER

Rice porridge+1.50 gr mulberry fruit powdered extract

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lambda Therapeutic Research Ltd.

INDUSTRY

Sponsor Role: collaborator

Unilever R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Mela, Dr.

Role: STUDY_DIRECTOR

Unilever R&D Vlaardingen (retired)

Locations

Lambda Therapeutics Research Ttd (LTRL)

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

FDS-NAA-0720

Identifier Type: -

Identifier Source: org_study_id