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

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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

Tracking Information
First Submitted Date  ICMJE January 31, 2020
First Posted Date  ICMJE February 6, 2020
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE November 24, 2011
Actual Primary Completion Date January 6, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
  • 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"
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 4, 2020)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Exploratory Study of Efficacy on Selected Natural Extracts Reducing Post Prandial Blood Glucose Response
Official Title  ICMJE 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
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Blood Glucose
Intervention  ICMJE
  • Other: Mulberry fruit
  • Other: Mulberry leaf
  • Other: White bean
  • Other: Apple
  • Other: Elderberry
  • Other: Turmeric
  • Other: Rice porridge
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Interventions:
    • 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
    Interventions:
    • Other: Elderberry
    • Other: Turmeric
  • Placebo Comparator: Rice porridge control
    Bowl containing 60 g of extruded rice + 300 ml of boiling water
    Intervention: Other: Rice porridge
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2020)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 6, 2012
Actual Primary Completion Date January 6, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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?
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04258501
Other Study ID Numbers  ICMJE FDS-NAA-0334
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Unilever R&D
Study Sponsor  ICMJE Unilever R&D
Collaborators  ICMJE Lambda Therapeutic Research Ltd.
Investigators  ICMJE
Study Director: David Mela, Dr. Unilever R&D Vlaardingen (retired)
PRS Account Unilever R&D
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP