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Completed

NCT Number: NCT02662738

The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product

This study is to quantify the effect of a natural fruit extract added to a wheat product on the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

QPS

Groningen, Hanzeplein 1, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Caucasian male.
  • Body mass index (BMI) ≥ 18.0 and ≤ 25.0 kg/m2.
  • Apparently healthy: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
  • Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/liter (i.e. 62- 110 mg/dl) at screening.
  • HbA1c ≤ 6.5 % (48 mmol/mol).

Exclusion criteria

  • Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1.

Treatment and study plan

Natural fruit extract

Dietary Supplement

Placebo

Other

glucose solution

Other

Primary outcomes

  1. 13C (13 carbon) and D-[6,6-2H2] glucose

    Time frame: 0-6 hours

Secondary outcomes

  1. Total blood glucose (BG)

    Time frame: 0-2 hours and 0-4 hours

  2. Insulin

    Time frame: 0-2 hours and 0-4 hours

  3. Endogenous glucose production (EGP)

    Time frame: 0-2 hours and 0-4 hours

  4. Glucose clearance rate (GCR)

    Time frame: 0-2 hours and 0-4 hours

  5. 13C Metabolites of glucose (metabolomics)

    Time frame: 0-2 hours and 0-4 hours

  6. 12C Metabolites of glucose (metabolomics)

    Time frame: 0-2 hours and 0-4 hours

  7. Postprandial hormones (Gastric inhibitory polypeptide, glucagon-like peptide-1 and Glucagon)

    Time frame: 0-2 hours and 0-4 hours

  8. Selected anti-oxidants (vitamin E (alpha-tocopherol), lycopene, retinol, alpha-carotene and beta-carotene)

    Time frame: -5, 60, 120, 180, 240 and 300 minutes

  9. Haematocrit

    Time frame: -5, 60, 120, 180, 240 and 300 minutes

  10. Concentration of key active in extract

    Time frame: -5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 and 360 minutes

  11. 13CO2 in breath

    Time frame: 30, 30, 60, 90,120, 150, 180 and every 30 minutes up to 6 hours

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2016
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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