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

Unilever

Status: Completed

Conditions: Blood Glucose

Treatments: Other: Boiled Rice; Other: Boiled Rice+0.75 gr mulberry fruit powdered extract; Other: Boiled Rice+1.50 gr mulberry fruit powdered extract; Other: Rice Porridge; Other: Boiled Rice+1.12 gr mulberry fruit powdered extract; Other: Rice porridge+1.50 gr mulberry fruit powdered extract; Other: Boiled Rice+0.37 gr mulberry fruit powdered extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT04256746

FDS-NAA-0720

Details and patient eligibility

About

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).

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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84 participants in 7 patient groups, including a placebo group

Boiled Rice

Placebo Comparator group

Description:

63 g of raw rice was cooked.

Treatment:

Other: Boiled Rice

Boiled Rice+0.37 gr extract

Experimental group

Description:

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

Treatment:

Other: Boiled Rice+0.37 gr mulberry fruit powdered extract

Boiled Rice+0.75 gr extract

Experimental group

Description:

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

Treatment:

Other: Boiled Rice+0.75 gr mulberry fruit powdered extract

Boiled Rice+1.12 gr extract

Experimental group

Description:

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

Treatment:

Other: Boiled Rice+1.12 gr mulberry fruit powdered extract

Boiled Rice+1.50 gr extract

Experimental group

Description:

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

Treatment:

Other: Boiled Rice+1.50 gr mulberry fruit powdered extract

Rice porridge

Placebo Comparator group

Description:

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

Treatment:

Other: Rice Porridge

Rice porridge+1.50 gr extract

Active Comparator group

Description:

60 g of rice porridge was rehydrated with 300 ml boiling hot water and 1.50 gr mulberry fruit powdered extract added and mixed

Treatment:

Other: Rice porridge+1.50 gr mulberry fruit powdered extract