Glucose Kinetics After Wheat and Rye Breads | NCT03581266

Studies
Glucose Kinetics After Wheat and Rye Breads

NCT03581266

Sponsor

Swedish University of Agricultural Sciences

Status

Completed

Last Update Posted

Jul 10, 2018Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2. Physiology of Glucose Kinetics

Interventions

Rye/Wheat

Countries

Not provided

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

Jun 2018

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

Jun 1, 2015Actual

Primary Completion Date

Nov 30, 2015Actual

Completion Date

Nov 30, 2015Actual

First Submitted Date

Jun 26, 2018

First Submission Date that Met QC Criteria

Jun 26, 2018

First Posted Date

Jul 10, 2018Actual

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

Jun 26, 2018

Last Update Posted Date

Jul 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ali A Moazzami, Associate professor, PhD, Swedish University of Agricultural SciencesPrincipal Investigator

Lead Sponsor

Swedish University of Agricultural SciencesOTHER

Collaborators

Name	Class
Uppsala University	OTHER
CTC Clinical Trial Consultants AB	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Certain functional properties of cereal products, e.g. their postprandial glucose and insulin responses, have been characterized as steps towards obtaining a greater understanding of their beneficial health effects. A low-glycemic index diet results in decreased postprandial insulin and glucose responses, which is thought to be beneficial for insulin and glucose metabolism.

In healthy subjects, it has been shown that rye breads (RBs) produce a lower postprandial insulin response compared with refined wheat breads (RWB) despite similar glucose responses. Juntunen et al. (2003) suggested that the difference in the structural characteristics between rye and wheat breads is a possible explanatory mechanism. However, the underlying mechanism of this discrepancy between insulin and glucose responses to rye bread, the so-called "rye factor" (RF), is still largely unknown. Faster starch digestibility and higher postprandial insulin responses for RWB compared with RBs may indicate faster intestinal glucose absorption and faster glucose disappearance respectively.

Therefore our hypothesis is that despite having similar glucose responses, RWB has faster turn over (kinetics) compared with RBs. The present study is aiming to apply an experimental set up which can comprehend the hypothetical differences in RWB and RBs kinetics.

Detailed Description

The human subjects after an overnight fasting 10-12 hours are coming to the clinic. On arrival, catheters are inserted into a forearm vein of each arm for blood sampling and isotope infusion, respectively. A primed followed by a constant-rate infusion of [6,6-2H2] glucose are administered. The enrichment of [6,6-2H2] glucose in the blood is then measured at different time points after the breakfast. The glucose kinetics can be calculated from this.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rye	Experimental	A breakfast consisting of whole slices of wholemeal rye bread containing 50 g of available carbohydrates. The breakfast additionally included 250 mL water and 50 g of cucumber.	Other: Rye/Wheat
Wheat	Experimental	A breakfast consisting of whole slices of refined wheat bread containing 50 g of available carbohydrates. The breakfast additionally included 250 mL water and 50 g of cucumber.	Other: Rye/Wheat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rye/Wheat	Other	Mechanistic study of glucose kinetics after ingestion two kinds of bread	Rye Wheat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigate glucose kinetics after ingestion of wheat and rye breads	Glucose kinetics are investigated after ingestions of two different kinds of bread based breakfasts in order to see how the body responds to the different breads.	Completed and published study within 3 years after end of sample collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males 18-40 years with BMI 22-25.5 kg/m2

Exclusion Criteria:

A family history of diabetes mellitus, regular use of nicotine, recurrent extensive exercise, regular intake of medication or food intolerances. The subjects had to be free from illnesses for one month prior to the study.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only males were recruited

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ali A Moazzami, PhD	Swedish University of Agricultural Sciences	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

The study was carried out using a crossover design with a three-week washout period. The participants stayed overnight at the facility and had one out of two types of breakfast in the morning.