The Effect of a Natural Extract on Glucose Fluxes After C... | NCT02662738

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

NCT02662738

Sponsor

Unilever R&D

Status

Completed

Last Update Posted

Oct 26, 2016Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Natural fruit extract
Placebo
Glucose solution

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jan 20, 2016

First Submission Date that Met QC Criteria

Jan 20, 2016

First Posted Date

Jan 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Natural fruit extract	Dietary Supplement		A wheat product
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tjeerd Mensinga, MD, PhD	QPS Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
QPS		Groningen	Hanzeplein 1	9713 GZ	Netherlands