Exploratory Study of Efficacy on Selected Natural Extracts Reducing Post Prandial Blood Glucose Response

An Exploratory Study of Efficacy and Tolerance on Selected Natural Extracts, With the Potential of Reducing Post Prandial Blood Glucose Response, in Healthy Indian Adult Subjects

Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).

Study Overview

• Status: Completed
• Conditions: Blood Glucose
• Intervention / Treatment: Other: Mulberry fruit; Other: Mulberry leaf; Other: White bean; Other: Apple; Other: Elderberry; Other: Turmeric; Other: Rice porridge

Detailed Description

Incomplete block design cross over study in which the subjects consumed commercial rice porridge (60 grams of extruded rice to which 300 ml of boiling water was added) in the morning in a fasted state. On each visit one of the seven different natural exacts was mixed into this porridge just before consumption. The reference was consumed by all subjects and consisted of plain porridge with no extract added.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 382481
      • Lambda Therapeutics Research Ttd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is the volunteer willing to give his consent to participate in the study in writing?
2. Is the volunteer between the age of >20 and <50 yrs?
3. Is the volunteer's Body Mass Index (BMI) in between >18 and <25 kg/m2?
4. Lactase deficient as indicated by screening test1
5. Is the volunteer apparently healthy? [No medical conditions which might affect study measurement, as judged by study physician or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis]
6. Is the volunteer willing to comply to study protocol during the study?
7. Is the volunteer agreeing to be informed about medically relevant personal test-results by study physician?
8. Is the volunteer willing to refrain from drinking of alcohol on and one day before the blood withdrawal?
9. Is the fasting blood glucose value of the volunteer is >3.4 and <6.1 mmol/ litre (i.e. 62-110 mg/dl)?
10. Is the Haemoglobin level within normal reference range as judged by the research physician?
11. Is the volunteer literate?

Exclusion Criteria:

1. Is the volunteer an employee of Unilever, Hindustan Lever, or Lambda Therapeutics Research?
2. Has the volunteer participated in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the study period?
3. Does the volunteer take too much of alcohol (> 120 ml / week)?
4. Is the volunteer on a medically prescribed/slimming diet?
5. Does the volunteer work in night shifts (between 23.00 and 6.00 hrs) in the week preceding or during the study?
6. Is the volunteer using any medication including traditional medicines, vitamins, tonics which might interfere with study measurements, as judged by the PI and/or study physician?
7. Does the volunteer engage in intense exercise > 10h/week? (Intense exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation)
8. Has the volunteer reported weight loss/gain > 10% of body weight in the 6 months preceding screening?
9. Has the volunteer donated any blood for 2 months prior to screening visit?
10. Does the volunteer urine analysis show any drug abuse?
11. Is the volunteer allergic to any food or cosmetics?
12. Does the volunteer smoke or consume tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study?
13. If female, is the volunteer pregnant or will she be planning pregnancy during the study period?
14. If female, is the volunteer lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mulberry fruit extract; 1.5 g of mulberry fruit powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: Mulberry fruit
Experimental: Mulberry leaf extract; 1.0 g of mulberry leaf powdered extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: Mulberry leaf
Experimental: White bean extract; 3 g of white bean powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: White bean
Experimental: Apple extract; 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: Apple
Experimental: Elderberry extract; 2 g of elderberry powder extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: Elderberry
Experimental: Turmeric extract; 0.18 g of curcumin powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: Turmeric
Experimental: Turmeric extract + Apple extract; 0.18 g of curcumin powdered extract + 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: Apple; Other: Turmeric
Experimental: Turmeric extract + Elderberry extract; 0.18 g of curcumin powdered extract + 2 g of elderberry powder extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: Elderberry; Other: Turmeric
Placebo Comparator: Rice porridge control; Bowl containing 60 g of extruded rice + 300 ml of boiling water	Other: Rice porridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial blood glucose	Glucose concentration in venous plasma	Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breath hydrogen excretion	Hydrogen gas in exhaled breath. When a subject produced 10 ppm hydrogen or more above the basal breath hydrogen level the treatment was regarded as a "positive"	Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products
Intestinal discomfort	An intestinal discomfort questionnaire was administered. The questionnaire asked whether subjects had experienced 1) flatulence, 2) nausea, 3) bloating or 4) pain in the bowels. Percentage of "Yes" scores was calculated per discomfort.	Ten minutes before (baseline) and at 130, 250, 370 and 420 minutes after the ingestion of the test products.
Stool consistency and number of stools	Stool consistency was evaluated by semi-quantitative Bristol scale (score between 1 = constipation and 7 = watery diarrhea).	24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial serum insulin	Post-prandial serum insulin Area under versus time curves	Total Area under the insulin versus time Curve 0-2 hours after the intake.
Glucose in urine	Glucose in urine was measured using dipsticks with a detection limit of 2.28 mmol/L	Subjects were asked to empty their bladder before study product intake (-20 minutes) and again before leaving the site ( 450 minutes). In these two samples and in all additional urine samples voided while subjects were on site, glucose was analyzed

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Lambda Therapeutic Research Ltd.
• Investigators: Study Director: David Mela, Dr., Unilever R&D Vlaardingen (retired)

Publications and helpful links

General Publications

• Mela DJ, Cao XZ, Dobriyal R, Fowler MI, Lin L, Joshi M, Mulder TJP, Murray PG, Peters HPF, Vermeer MA, Zhang Z. The effect of 8 plant extracts and combinations on post-prandial blood glucose and insulin responses in healthy adults: a randomized controlled trial. Nutr Metab (Lond). 2020 Jul 6;17:51. doi: 10.1186/s12986-020-00471-x. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2011
• Primary Completion (Actual): January 6, 2012
• Study Completion (Actual): January 6, 2012

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: FDS-NAA-0334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No