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

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)

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Dietary supplement: Natural fruit extract; Other: Glucose solution

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Hanzeplein 1
    • Groningen, Hanzeplein 1, Netherlands, 9713 GZ
      • QPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Investigators: Principal Investigator: Tjeerd Mensinga, MD, PhD, QPS Netherlands

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Blood glucose
• Other Study ID Numbers: FDS-NAA-1650