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

NCT04258501 | Completed

• 1 other identifier: FDS-NAA-0334
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Glucose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Breath hydrogen excretion

  Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products

• Intestinal 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

  24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview).

Other Outcomes (2)

• Post-prandial serum insulin

  Total Area under the insulin versus time Curve 0-2 hours after the intake.

• Glucose in urine

  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

Study Arms (9)

Mulberry fruit extract

EXPERIMENTAL

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

Mulberry leaf extract

EXPERIMENTAL

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

White bean extract

EXPERIMENTAL

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

Apple extract

EXPERIMENTAL

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

Elderberry extract

EXPERIMENTAL

2 g of elderberry powder extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water

Other: Elderberry

Turmeric extract

EXPERIMENTAL

0.18 g of curcumin powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water

Other: Turmeric

Turmeric extract + Apple extract

EXPERIMENTAL

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

Turmeric extract + Elderberry extract

EXPERIMENTAL

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

Rice porridge control

PLACEBO COMPARATOR

Bowl containing 60 g of extruded rice + 300 ml of boiling water

Other: Rice porridge

Interventions

Mulberry fruit OTHER

Mulberry fruit extract

Mulberry leaf OTHER

Mulberry leaf extract

White bean OTHER

White bean extract

Apple OTHER

Apple extract; Turmeric extract + Apple extract

Elderberry OTHER

Elderberry extract; Turmeric extract + Elderberry extract

Turmeric OTHER

Turmeric extract; Turmeric extract + Apple extract; Turmeric extract + Elderberry extract

Rice porridge OTHER

Rice porridge control

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Is the volunteer an employee of Unilever, Hindustan Lever, or Lambda Therapeutics Research?
• 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?
• Does the volunteer take too much of alcohol (\> 120 ml / week)?
• Is the volunteer on a medically prescribed/slimming diet?
• Does the volunteer work in night shifts (between 23.00 and 6.00 hrs) in the week preceding or during the study?
• 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?
• 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)
• Has the volunteer reported weight loss/gain \> 10% of body weight in the 6 months preceding screening?
• Has the volunteer donated any blood for 2 months prior to screening visit?
• Does the volunteer urine analysis show any drug abuse?
• Is the volunteer allergic to any food or cosmetics?
• 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?
• If female, is the volunteer pregnant or will she be planning pregnancy during the study period?
• If female, is the volunteer lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period?

Sponsors & Collaborators

• Unilever R&D: lead
• Lambda Therapeutic Research Ltd.: collaborator

Study Sites (1)

Lambda Therapeutics Research Ttd

Ahmedabad, Gujarat, 382481, India

Location

Related Publications (1)

• 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.

  PMID: 32647531 DERIVED

MeSH Terms

Interventions

Morus alba; elderberry extract; Curcumin

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• David Mela, Dr.

  Unilever R&D Vlaardingen (retired)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: November 24, 2011
• Primary Completion: January 6, 2012
• Study Completion: January 6, 2012
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)