Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level

NCT02599740 | Completed

• 1 other identifier: FDS-NAA-2093
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.

Conditions

Healthy

Keywords

Blood glucose

Outcome Measures

Primary Outcomes (1)

• Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments

  +iAUC

  0-2 hours

Secondary Outcomes (7)

• Change of 3-h PPG based on response to different treatments

  0-3 hours

• Change of 2-h and 3-h post-prandial insulin based on response to different treatments

  0-2 hours and 0-3 hours

• Max plasma concentration for assumed key active

  0-12 hours

• Time of max plasma concentration for assumed key active

  0-12 hours

• AUC for plasma concentration versus time curve for assumed key active

  0-12 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Rice only

Other: Placebo

Assumed active

ACTIVE COMPARATOR

Assumed key active consumed with rice

Other: Assumed active

Natural fruit extract

ACTIVE COMPARATOR

Natural fruit extract consumed with rice

Other: Natural fruit extract

Interventions

Natural fruit extract OTHER

Natural fruit extract consumed with rice

Natural fruit extract

Assumed active OTHER

Assumed key active consumed with rice

Assumed active

Placebo OTHER

Rice only

Placebo

Eligibility Criteria

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

You may qualify if:

• Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m2.
• Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery \[with exception of cholecystectomy and appendectomy\] and inflammatory diseases).
• Fasting blood glucose value of subjects is ≥ 3.4 and \<6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening.

You may not qualify if:

• Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.

Sponsors & Collaborators

• Unilever R&D: lead

Study Sites (1)

Charité Research Organisation GmbH

Berlin, Germany

Location

Related Publications (1)

• Hoogenraad AR, Geldof M, Hiemstra H, de Jong A, Duchateau GS, Mela DJ. Bioequivalence of Mulberry Fruit Extract and 1-Deoxynojirimycin for Postprandial Blood Glucose Lowering: A Randomized Trial in Humans. J Nutr. 2025 Jul;155(7):2164-2171. doi: 10.1016/j.tjnut.2025.05.037. Epub 2025 May 24.

  PMID: 40419090 DERIVED

Study Officials

• Christian Keicher, Dr

  Charité Research Organisation GmbH

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 9, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

DE (1)