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

NCT04256746 | Completed

• 1 other identifier: FDS-NAA-0720
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Glucose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-prandial insulin

  Total area under the insulin versus time curves between 0 (before) and 2 hours after study product intake

Other Outcomes (2)

• Hydrogen gas in exhaled breath

  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

  Just before and at 430 minutes after study product administration

Study Arms (7)

Boiled Rice

PLACEBO COMPARATOR

63 g of raw rice was cooked.

Other: Boiled Rice

Boiled Rice+0.37 gr extract

EXPERIMENTAL

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

Boiled Rice+0.75 gr extract

EXPERIMENTAL

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

Boiled Rice+1.12 gr extract

EXPERIMENTAL

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

Boiled Rice+1.50 gr extract

EXPERIMENTAL

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

Rice porridge

PLACEBO COMPARATOR

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

Other: Rice Porridge

Rice porridge+1.50 gr extract

ACTIVE COMPARATOR

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

Interventions

Boiled Rice OTHER

Boiled Rice

Boiled Rice+0.37 gr mulberry fruit powdered extract OTHER

Boiled Rice+0.37 gr extract

Boiled Rice+0.75 gr mulberry fruit powdered extract OTHER

Boiled Rice+0.75 gr extract

Boiled Rice+1.12 gr mulberry fruit powdered extract OTHER

Boiled Rice+1.12 gr extract

Boiled Rice+1.50 gr mulberry fruit powdered extract OTHER

Boiled Rice+1.50 gr extract

Rice Porridge OTHER

Rice porridge

Rice porridge+1.50 gr mulberry fruit powdered extract OTHER

Rice porridge+1.50 gr extract

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 ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead
• Lambda Therapeutic Research Ltd.: collaborator

Study Sites (1)

Lambda Therapeutics Research Ttd (LTRL)

Ahmedabad, Gujarat, 382481, India

Location

Study Officials

• David Mela, Dr.

  Unilever R&D Vlaardingen (retired)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The coded and un-coded randomization schedule was generated by the bio-statistician of CRO. The person involved in the preparation of the test product was not involved in any other activities related to the study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, balanced incomplete block design dose response study of efficacy,

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: September 24, 2012
• Primary Completion: October 19, 2012
• Study Completion: October 19, 2012
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

IN (1)