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

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ClinicalTrials.gov Identifier: NCT02662738
Recruitment Status : Completed
First Posted : January 25, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Natural fruit extract Other: Placebo Other: Glucose solution Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product
Study Start Date : January 2016
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A wheat product
A wheat product (containing 2% 13C-universally-labeled wheat) with natural fruit extract added.
 Dietary Supplement: Natural fruit extract
Placebo Comparator: Control
A wheat product (containing 2% 13C-universally-labeled wheat) without natural fruit extract added.
 Other: Placebo
Glucose solution
A solution of 50g glucose of which 2% 13C-universally-labeled glucose (2%) and unlabeled glucose (98%) in 250 mL water.
 Other: Glucose solution


Outcome Measures
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Primary Outcome Measures :
  1. 13C (13 carbon) and D-[6,6-2H2] glucose [ Time Frame: 0-6 hours ]

Secondary Outcome Measures :
  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 ]

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

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.
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): NCT02662738


Locations
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Netherlands
QPS
Groningen, Hanzeplein 1, Netherlands, 9713 GZ
Sponsors and Collaborators
Unilever R&D
Investigators
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Principal Investigator: Tjeerd Mensinga, MD, PhD QPS Netherlands
More Information
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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT02662738    
Other Study ID Numbers: FDS-NAA-1650
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by Unilever R&D:
Blood glucose