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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02662738
Enrollment
12
Registered
2016-01-25
Start date
2016-01-31
Completion date
2016-02-29
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Blood glucose

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)

Interventions

DIETARY_SUPPLEMENTNatural fruit extract
OTHERPlacebo
OTHERGlucose solution

Sponsors

Unilever R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
13C (13 carbon) and D-[6,6-2H2] glucose0-6 hours

Secondary

MeasureTime frame
Insulin0-2 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
Total blood glucose (BG)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 breath30, 30, 60, 90,120, 150, 180 and every 30 minutes up to 6 hours
Postprandial hormones (Gastric inhibitory polypeptide, glucagon-like peptide-1 and Glucagon)0-2 hours and 0-4 hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026