Clinical trial NCT04256746: Dose Response Study of a Natural Extract for Reducing Post Prandial Blood Glucose
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Lambda Therapeutic Research Ltd.
First posted: 2020-02-05
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, balanced incomplete block design dose response study of efficacy,
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Post-prandial blood glucose
timeFrame: Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours after test product intake
Secondary outcomes:
measure: Post-prandial insulin
timeFrame: Total area under the insulin versus time curves between 0 (before) and 2 hours after study product intake
Other outcomes:
measure: Hydrogen gas in exhaled breath
timeFrame: 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
measure: Intestinal discomfort
timeFrame: Just before and at 430 minutes after study product administration
Locations:
city: Ahmedabad
country: India
facility: Lambda Therapeutics Research Ttd (LTRL)
state: Gujarat
Study officials:
affiliation: Unilever R&D Vlaardingen (retired)
name: David Mela, Dr.
role: STUDY_DIRECTOR
References: