NCT02400411

Brief Summary

This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses elicited by meals containing either whole grain rye bread or white wheat bread as such or combined with margarine and ham and vegetable soup are compared. Blood glucose concentrations are monitored from finger prick blood samples collected before the meal and at 15, 30, 45, 60, 90 and 120 min. Venous samples for insulin concentrations are taken at time-points 0, 30 and 60 min.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Status
unknown

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

March 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

March 17, 2015

Last Update Submit

September 3, 2015

Conditions

Blood Glucose Concentration

Keywords

CarbohydrateGlycemic responseinsulinwhole grainmeal

Outcome Measures

Primary Outcomes (1)

  • Blood glucose concentration

    120 min

Secondary Outcomes (1)

  • Serum insulin concentration

    60 min

Study Arms (6)

Wheat bread

EXPERIMENTAL

Bread-based meal

Other: Wheat bread

Wheat bread with margarine and ham

EXPERIMENTAL

Bread-based meal

Other: Wheat breadOther: margarineOther: ham

Wheat bread with margarine, ham and soup

EXPERIMENTAL

Bread-based meal

Other: Wheat breadOther: margarineOther: hamOther: soup

Rye bread

EXPERIMENTAL

Bread-based meal

Other: rye bread

Rye bread with margarine and ham

EXPERIMENTAL

Bread-based meal

Other: margarineOther: hamOther: rye bread

Rye bread with margarine, ham and soup

EXPERIMENTAL

Bread-based meal

Other: margarineOther: hamOther: soupOther: rye bread

Interventions

Wheat breadOTHER
Wheat breadWheat bread with margarine and hamWheat bread with margarine, ham and soup
margarineOTHER
Rye bread with margarine and hamRye bread with margarine, ham and soupWheat bread with margarine and hamWheat bread with margarine, ham and soup
hamOTHER
Rye bread with margarine and hamRye bread with margarine, ham and soupWheat bread with margarine and hamWheat bread with margarine, ham and soup
soupOTHER
Rye bread with margarine, ham and soupWheat bread with margarine, ham and soup
rye breadOTHER
Rye breadRye bread with margarine and hamRye bread with margarine, ham and soup

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • BMI 18-27 kg/m2

You may not qualify if:

  • pregnant or breastfeeding
  • diabetes, gastrointestinal disease
  • regular use of medication
  • strict vegetarian or vegan diet
  • food allergy
  • recent blood donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin Resistance

Interventions

MargarineATF7IP protein, human

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 27, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09