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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04258501
Recruitment Status : Completed
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
Lambda Therapeutic Research Ltd.
Information provided by (Responsible Party):
Unilever R&D

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Blood Glucose Other: Mulberry fruit Other: Mulberry leaf Other: White bean Other: Apple Other: Elderberry Other: Turmeric Other: Rice porridge Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Randomization was generated by the bio-statistician CRO. Subjects and key study team personnel were blinded as much as possible with regard to the identification of specific treatments but their distinctive colors, flavors or tastes could not be masked.

To ensure the study team was not apparently aware of the treatments being administered to subjects, persons who were involved in the preparation of test products were not involved in rest of the study.

The sponsors team was blinded.
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : November 24, 2011
Actual Primary Completion Date : January 6, 2012
Actual Study Completion Date : January 6, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Post-prandial blood glucose [ Time Frame: Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours. ]
    Glucose concentration in venous plasma


Secondary Outcome Measures :
  1. Breath hydrogen excretion [ Time Frame: Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products ]
    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"

  2. Intestinal discomfort [ Time Frame: Ten minutes before (baseline) and at 130, 250, 370 and 420 minutes after the ingestion of the test products. ]
    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.

  3. Stool consistency and number of stools [ Time Frame: 24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview). ]
    Stool consistency was evaluated by semi-quantitative Bristol scale (score between 1 = constipation and 7 = watery diarrhea).


Other Outcome Measures:
  1. Post-prandial serum insulin [ Time Frame: Total Area under the insulin versus time Curve 0-2 hours after the intake. ]
    Post-prandial serum insulin Area under versus time curves

  2. Glucose in urine [ Time Frame: 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 ]
    Glucose in urine was measured using dipsticks with a detection limit of 2.28 mmol/L


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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?
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258501


Locations
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India
Lambda Therapeutics Research Ttd
Ahmedabad, Gujarat, India, 382481
Sponsors and Collaborators
Unilever R&D
Lambda Therapeutic Research Ltd.
Investigators
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Study Director: David Mela, Dr. Unilever R&D Vlaardingen (retired)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT04258501    
Other Study ID Numbers: FDS-NAA-0334
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No