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

Sponsor

Unilever R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT02662738

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jan 1, 2016

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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
Other: 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

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

Other: 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

Primary Outcome Measures

13C (13 carbon) and D-[6,6-2H2] glucose [0-6 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QPS	Groningen	Hanzeplein 1	Netherlands	9713 GZ

Sponsors and Collaborators

Unilever R&D

Investigators

Principal Investigator: Tjeerd Mensinga, MD, PhD, QPS Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unilever R&D

ClinicalTrials.gov Identifier:

NCT02662738

Other Study ID Numbers:

FDS-NAA-1650

First Posted:

Jan 25, 2016

Last Update Posted:

Oct 26, 2016

Last Verified:

Oct 1, 2016

Keywords provided by Unilever R&D

Blood glucose

Study Results

No Results Posted as of Oct 26, 2016