NCT03275948

Brief Summary

The purpose of the study is to investigate, in healthy middle age subjects, effects of whole grain rye on cognitive functions, mood, and cardiovasculair risk markers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2017

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

September 6, 2017

Last Update Submit

October 2, 2017

Conditions

Metabolic Disorders and Cognitive Decline

Outcome Measures

Primary Outcomes (1)

  • cognitive performance

    test of working memory capacity

    postprandial 0-180 min after breakfast

Secondary Outcomes (1)

  • glucose tolerance

    0-180 min after breakfast

Study Arms (2)

whole grain

EXPERIMENTAL
Other: whole grain

refrence

OTHER

white wheat based product

Other: reference

Interventions

whole grainOTHER

whole grain rye

whole grain
referenceOTHER

white wheat bread

refrence

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy
  • BMI 19-28
  • plasma glucose \< 6.1 mmol/L
  • non smooker

You may not qualify if:

  • known metabolic diseases
  • known gastrointestinal disorders
  • known cognitive decline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sandberg JC, Bjorck IME, Nilsson AC. Impact of rye-based evening meals on cognitive functions, mood and cardiometabolic risk factors: a randomized controlled study in healthy middle-aged subjects. Nutr J. 2018 Nov 6;17(1):102. doi: 10.1186/s12937-018-0412-4.

    PMID: 30400947DERIVED

MeSH Terms

Conditions

Metabolic DiseasesCognitive Dysfunction

Interventions

Whole Grains

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Edible GrainCrops, AgriculturalFoodDiet, Food, and NutritionPhysiological PhenomenaSeedsFood and Beverages

Study Design

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

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 8, 2017

Study Start

November 1, 2016

Primary Completion

February 28, 2017

Study Completion

October 2, 2017

Last Updated

October 4, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share