Effects of Whole Grain Rye on Metabolic Risk Markers and... | NCT03275948

Studies
Effects of Whole Grain Rye on Metabolic Risk Markers and Mood

NCT03275948

Sponsor

Lund University

Status

Completed

Last Update Posted

Oct 4, 2017Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Metabolic Disorders and Cognitive Decline

Interventions

whole grain
reference

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

Oct 2017

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

Nov 1, 2016Actual

Primary Completion Date

Feb 28, 2017Actual

Completion Date

Oct 2, 2017Actual

First Submitted Date

Sep 6, 2017

First Submission Date that Met QC Criteria

Sep 6, 2017

First Posted Date

Sep 8, 2017Actual

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

Oct 2, 2017

Last Update Posted Date

Oct 4, 2017Actual

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

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

Detailed Description

Not provided

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

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
whole grain	Experimental		Other: whole grain
refrence	Other	white wheat based product	Other: reference

Interventions

Name	Type	Description	Arm Group Labels	Other Names
whole grain	Other	whole grain rye	whole grain
reference

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cognitive performance	test of working memory capacity	postprandial 0-180 min after breakfast

Secondary Outcomes

Measure	Description	Time Frame
glucose tolerance	postprandial glucose concentrations	0-180 min after breakfast

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30400947	Derived	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.

ID	Term
D008659	Metabolic Diseases
D060825	Cognitive Dysfunction

ID	Term
D009750	Nutritional and Metabolic Diseases
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
D002523	Edible Grain
D018556	Crops, Agricultural
D005502	Food
D000066888	Diet, Food, and Nutrition