MedDataX Logo

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

NCT ID: NCT02662738

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Blood glucose

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A wheat product

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

Group Type ACTIVE_COMPARATOR

Natural fruit extract

Intervention Type DIETARY_SUPPLEMENT

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Glucose solution

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

Group Type OTHER

Glucose solution

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Natural fruit extract

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Glucose solution

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tjeerd Mensinga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

QPS Netherlands

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

QPS

Groningen, Hanzeplein 1, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FDS-NAA-1650

Identifier Type: -

Identifier Source: org_study_id