NCT03581266

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

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

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
Last Updated

July 10, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 26, 2018

Last Update Submit

June 26, 2018

Conditions

Keywords

RyeWheatRye factorGlucose kinetics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Mechanistic study of glucose kinetics after ingestion two kinds of bread

RyeWheat

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly males were recruited
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ali A Moazzami, PhD

    Swedish University of Agricultural Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, PhD

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 10, 2018

Study Start

June 1, 2015

Primary Completion

November 30, 2015

Study Completion

November 30, 2015

Last Updated

July 10, 2018

Record last verified: 2018-06