Metabolic Disorders and Cognitive DeclineNCT03275948
Effects of Whole Grain Rye on Metabolic Risk Markers and Mood
A study testing whole grain and reference in people with Metabolic Disorders and Cognitive Decline, run by Lund University.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorders and Cognitive Decline
- What is being tested?
- whole grain and reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 2 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- BMI 19-28
- plasma glucose < 6.1 mmol/L
- non smooker
Who cannot join
- known metabolic diseases
- known gastrointestinal disorders
- known cognitive decline.
About this study
Official title: Effects of Whole Grain on Cognitive Performance and Mood, and the Relationships to Cardiometabolic Risk Markers
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
- Being tested
- whole grain, reference
- Medical subject headings
- Metabolic Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole grainOther
whole grain rye
referenceOther
white wheat bread
| Study group | Role | What they receive |
|---|---|---|
| whole grain | Experimental | Not described Receives: Other: whole grain |
| refrence | Other | white wheat based product Receives: Other: reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive performance
test of working memory capacity
Measured: postprandial 0-180 min after breakfast
Secondary outcomes (1)
glucose tolerance
postprandial glucose concentrations
Measured: 0-180 min after breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Nov 2016
- Primary completion28 Feb 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Disorders and Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Nilsson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275948
- Sponsor's protocol ID
- 2016/487
- Status last verified
- Oct 2017
- First submitted
- 6 Sep 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30400947
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Grain on Cognitive Performance and Mood, and the Relationships to Cardiometabolic Risk Markers
- ClinicalTrials.gov ID
- NCT03275948
- Acronym / sponsor ID
- 2016/487
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole grain | Experimental | Other: whole grain |
| refrence | Other | Other: referencewhite wheat based product |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy
- BMI 19-28
- plasma glucose < 6.1 mmol/L
- non smooker
Key exclusion criteria (3 listed)
- known metabolic diseases
- known gastrointestinal disorders
- known cognitive decline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole grainwhole grain rye | Other | whole grain |
| referencewhite wheat bread | Other | refrence |
Primary outcome
cognitive performance
Time frame: postprandial 0-180 min after breakfast
test of working memory capacity
1 secondary outcome
glucose tolerance
Time frame: 0-180 min after breakfast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Derived from this study: PubMed 30400947Sandberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing whole grain and reference in people with Metabolic Disorders and Cognitive Decline, run by Lund University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive performance (time frame: postprandial 0-180 min after breakfast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03275948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.