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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662738
• Other study ID #: FDS-NAA-1650
• Status: Completed
• Phase: N/A
• First received: January 20, 2016
• Last updated: October 25, 2016
• Start date: January 2016
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Natural fruit extract

Other:
• Placebo

• Glucose solution

Locations

Country	Name	City	State
Netherlands	QPS	Groningen	Hanzeplein 1

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	13C (13 carbon) and D-[6,6-2H2] glucose		0-6 hours	No
Secondary	Total blood glucose (BG)		0-2 hours and 0-4 hours	No
Secondary	Insulin		0-2 hours and 0-4 hours	No
Secondary	Endogenous glucose production (EGP)		0-2 hours and 0-4 hours	No
Secondary	Glucose clearance rate (GCR)		0-2 hours and 0-4 hours	No
Secondary	13C Metabolites of glucose (metabolomics)		0-2 hours and 0-4 hours	No
Secondary	12C Metabolites of glucose (metabolomics)		0-2 hours and 0-4 hours	No
Secondary	Postprandial hormones (Gastric inhibitory polypeptide, glucagon-like peptide-1 and Glucagon)		0-2 hours and 0-4 hours	No
Secondary	Selected anti-oxidants (vitamin E (alpha-tocopherol), lycopene, retinol, alpha-carotene and beta-carotene)		-5, 60, 120, 180, 240 and 300 minutes	No
Secondary	Haematocrit		-5, 60, 120, 180, 240 and 300 minutes	No
Secondary	Concentration of key active in extract		-5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 and 360 minutes	No
Secondary	13CO2 in breath		30, 30, 60, 90,120, 150, 180 and every 30 minutes up to 6 hours	No