NCT02662738

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

January 20, 2016

Last Update Submit

October 25, 2016

Conditions

Healthy

Keywords

Blood glucose

Outcome Measures

Primary Outcomes (1)

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

    0-6 hours

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (3)

A wheat product

ACTIVE COMPARATOR

A wheat product (containing 2% 13C-universally-labeled wheat) with natural fruit extract added.

Dietary Supplement: Natural fruit extract

Control

PLACEBO COMPARATOR

A wheat product (containing 2% 13C-universally-labeled wheat) without natural fruit extract added.

Other: Placebo

Glucose solution

OTHER

A solution of 50g glucose of which 2% 13C-universally-labeled glucose (2%) and unlabeled glucose (98%) in 250 mL water.

Other: Glucose solution

Interventions

Natural fruit extractDIETARY_SUPPLEMENT
A wheat product
PlaceboOTHER
Control
Glucose solutionOTHER
Glucose solution

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QPS

Groningen, Hanzeplein 1, 9713 GZ, Netherlands

Location

Study Officials

  • Tjeerd Mensinga, MD, PhD

    QPS Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 25, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

NL(1)