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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Natural fruit extract; Other: Glucose solution; Other: Placebo

• Registration Number: NCT02662738
• Lead Sponsor: Unilever R&D

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A wheat product	Natural fruit extract	A wheat product (containing 2% 13C-universally-labeled wheat) with natural fruit extract added.
Glucose solution	Glucose solution	A solution of 50g glucose of which 2% 13C-universally-labeled glucose (2%) and unlabeled glucose (98%) in 250 mL water.
Control	Placebo	A wheat product (containing 2% 13C-universally-labeled wheat) without natural fruit extract added.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

QPS; 🇳🇱 Groningen, Hanzeplein 1, Netherlands