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

Study Overview
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Brief Summary
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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)

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Natural fruit extract
* Other: Placebo
* Other: Glucose solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13C (13 carbon) and D-[6,6-2H2] glucose |  | 0-6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood glucose (BG) |  | 0-2 hours and 0-4 hours | 
| Insulin |  | 0-2 hours and 0-4 hours | 
| Endogenous glucose production (EGP) |  | 0-2 hours and 0-4 hours | 
| Glucose clearance rate (GCR) |  | 0-2 hours and 0-4 hours | 
| 13C Metabolites of glucose (metabolomics) |  | 0-2 hours and 0-4 hours | 
| 12C Metabolites of glucose (metabolomics) |  | 0-2 hours and 0-4 hours | 
| Postprandial hormones (Gastric inhibitory polypeptide, glucagon-like peptide-1 and Glucagon) |  | 0-2 hours and 0-4 hours | 
| Selected anti-oxidants (vitamin E (alpha-tocopherol), lycopene, retinol, alpha-carotene and beta-carotene) |  | -5, 60, 120, 180, 240 and 300 minutes | 
| Haematocrit |  | -5, 60, 120, 180, 240 and 300 minutes | 
| Concentration of key active in extract |  | -5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 and 360 minutes | 
| 13CO2 in breath |  | 30, 30, 60, 90,120, 150, 180 and every 30 minutes up to 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose