Back to resultsEffects of Whole Grain Rye on Metabolic Risk Markers and Mood
Primary Purpose
Metabolic Disorders and Cognitive Decline
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
whole grain
reference
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Disorders and Cognitive Decline
Eligibility Criteria
Inclusion Criteria:
- healthy
- BMI 19-28
- plasma glucose < 6.1 mmol/L
- non smooker
Exclusion Criteria:
- known metabolic diseases
- known gastrointestinal disorders
- known cognitive decline.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
whole grain
refrence
Arm Description
white wheat based product
Outcomes
Primary Outcome Measures
cognitive performance
test of working memory capacity
Secondary Outcome Measures
glucose tolerance
postprandial glucose concentrations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03275948
Brief Title
Effects of Whole Grain Rye on Metabolic Risk Markers and Mood
Official Title
Effects of Whole Grain on Cognitive Performance and Mood, and the Relationships to Cardiometabolic Risk Markers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
October 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disorders and Cognitive Decline
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
whole grain
Arm Type
Experimental
Arm Title
refrence
Arm Type
Other
Arm Description
white wheat based product
Intervention Type
Other
Intervention Name(s)
whole grain
Intervention Description
whole grain rye
Intervention Type
Other
Intervention Name(s)
reference
Intervention Description
white wheat bread
Primary Outcome Measure Information:
Title
cognitive performance
Description
test of working memory capacity
Time Frame
postprandial 0-180 min after breakfast
Secondary Outcome Measure Information:
Title
glucose tolerance
Description
postprandial glucose concentrations
Time Frame
0-180 min after breakfast
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
BMI 19-28
plasma glucose < 6.1 mmol/L
non smooker
Exclusion Criteria:
known metabolic diseases
known gastrointestinal disorders
known cognitive decline.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30400947
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Whole Grain Rye on Metabolic Risk Markers and Mood
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