Mild Cognitive ImpairmentNCT01620567
Consumption of Potatoes, Avocados and Chickpeas and Cognitive Function in Older Adults
A study testing avocado and potato or chickpea in people with Mild Cognitive Impairment, run by Tufts University at 1 site in United States.
Trial summary
Cognitive impairment is also a major risk factor for development of dementia later in life. Findings from the investigators studies suggest that the carotenoids, lutein and zeaxanthin may be important in cognitive function in the elderly. Avocados are a source of these carotenoids. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- avocado and potato or chickpea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women age > 50 years
- BMI 19-30 kg/m2
- lutein intake of < 3 mg/d
- Docosahexaenoic acid intake < 250 mg/d (including supplements)
- Mini mental state exam (MMSE) score > 24
- Macular pigment density < 0.4 at 0.5 degrees
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- Beck Depression Inventory < 20
- free of known disease
- BMI 19-29 kg/m2
- must be able to give written informed consent
- have normal hematologic parameters
- normal values of plasma albumin
- normal values for liver and kidney function (Appendix A)
- no use of carotenoid, n3 fatty acid, multivitamin/mineral, (> 2 months).
Who cannot join
- history of active small bowel disease or resection
- atrophic gastritis
- hyperlipidemia (LDL >120 mg/dL or triglycerides >150 mg/dL)
- hypertension (>150/90 mm Hg)
- diabetes, alcoholism (>2 drinks/d or 14 drinks/week)
- pancreatic disease
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- anemia, and bleeding disorders (as determined by screening interview)
- avocado, potato or chickpea allergy
- pregnancy or lactation
- diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibroids (as determined by screening interview)
- medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview)
- use of antipsychotic, antimanic, anti-inflammatory, monoamine inhibitors, or dementia medications
- smoking or use of nicotine patches or gum (within past 6 months)
- use of drugs suspected of interfering with metabolism of blood clotting, e.g. warfarin (as determined by screening interview)
- subjects having extremely high dietary intakes of carotenoids as indicated by screening plasma values > NHANES 95th percentile for lutein/zeaxanthin, beta-carotene, cryptoxanthin, or lycopene
- stroke,head injury with loss of consciousness or seizures.
- Non English speaking: This is a small study with a sample size. Logistically and financially, getting materials translated for such a small study is not feasible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: The Effect of Consumption of Potatoes, Avocados and Chickpeas Daily for 6 Months on Cognitive Function in Older Adults
Cognitive impairment is also a major risk factor for development of dementia later in life. Findings from the investigators studies suggest that the carotenoids, lutein and zeaxanthin may be important in cognitive function in the elderly. Avocados are a source of these carotenoids. The investigators study evaluates long-term avocado intervention as a treatment strategy for age-related cognitive impairment which could possibly prevent the onset of dementia. The investigators have also shown that lutein supplementation significantly improved verbal fluency scores in healthy older women. Based on these findings, the next logical step will be to investigate the ability of lutein and zeaxanthin contained in avocados to influence cognitive function in older adults. The investigators hypothesize that there will be a significant increase in cognitive function measures in older adults provided with meals containing 1 avocado/day at the end of 6 months, while no significant improvements will be observed in older adults given daily meals containing chickpeas and/or potatoes.
The proposed study is designed as a randomized, placebo controlled trial that tests the effects of 6 month supplementation with 1 avocado/day on cognitive function in older adults. Secondary analyses will determine whether baseline macular pigment (lutein in retina which canbe measured non invasivley) density predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation.
Read the detailed description
The study is designed as a placebo controlled trial that tests the effects of 6 month supplementation with daily meals containing 1 avocado or isocaloric amounts of chickpeas and/or potatoes on cognitive function in older adults. Subjects will be randomly assigned to one of the two groups. Secondary analyses will determine whether baseline macular pigment density (a non invasive measure of lutein and zeaxanthin in neural tissue) predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation. Participants will be recruited from community-dwelling men and women aged >50 yr, and potential participants will be screened to meet cognitive and functional criteria. Participants will be pre-screened by telephone; those who appear to meet criteria will undergo further screening. The study will include baseline (0 month), 3 and 6 month visits for study procedures, and monthly telephone calls. Given that there is a visible difference between the two interventions, a blinded study is not possible.
- Conditions
- Mild Cognitive Impairment
- Being tested
- avocado, potato or chickpea
- Keywords
- lutein, avocados, chickpeas, potatoes, elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avocadoOther
1 avocado/day for 6 months
potato or chickpeaOther
1 cup potatoes or chickpeas/day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| chickpeas/potatoes | Placebo comparator | 1 potato/day or 1 cup chickpeas Receives: Other: potato or chickpea |
| avocados | Active comparator | 1 avocados/day Receives: Other: avocado |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
measures of sustained attention will be made using CANTAB, a sensitive computerized program. Signal detection measured on a scale from 0 to 1(bad to good).
Measured: 6 months
Secondary outcomes (3)
Inflammation
C-reactive protein
Measured: 0 months
Inflammation
C-reactive protein
Measured: 3 month
Inflammation
C-reactive protein
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth J Johnson, Ph.D., Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620567
- Sponsor's protocol ID
- 002
- Status last verified
- May 2019
- First submitted
- 13 Jun 2012
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Consumption of Potatoes, Avocados and Chickpeas Daily for 6 Months on Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT01620567
- Acronym / sponsor ID
- 002
- Conditions
- Mild Cognitive Impairment
- Keywords
- lutein, avocados, chickpeas, potatoes, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive impairment is also a major risk factor for development of dementia later in life. Findings from the investigators studies suggest that the carotenoids, lutein and zeaxanthin may be important in cognitive function in the elderly. Avocados are a source of these carotenoids. The investigators study evaluates long-term avocado intervention as a treatment strategy for age-related cognitive impairment which could possibly prevent the onset of dementia. The investigators have also shown that lutein supplementation significantly improved verbal fluency scores in healthy older women. Based on these findings, the next logical step will be to investigate the ability of lutein and zeaxanthin contained in avocados to influence cognitive function in older adults. The investigators hypothesize that there will be a significant increase in cognitive function measures in older adults provided with meals containing 1 avocado/day at the end of 6 months, while no significant improvements will be observed in older adults given daily meals containing chickpeas and/or potatoes.
The proposed study is designed as a randomized, placebo controlled trial that tests the effects of 6 month supplementation with 1 avocado/day on cognitive function in older adults. Secondary analyses will determine whether baseline macular pigment (lutein in retina which canbe measured non invasivley) density predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation.
Detailed description
The study is designed as a placebo controlled trial that tests the effects of 6 month supplementation with daily meals containing 1 avocado or isocaloric amounts of chickpeas and/or potatoes on cognitive function in older adults. Subjects will be randomly assigned to one of the two groups. Secondary analyses will determine whether baseline macular pigment density (a non invasive measure of lutein and zeaxanthin in neural tissue) predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation. Participants will be recruited from community-dwelling men and women aged >50 yr, and potential participants will be screened to meet cognitive and functional criteria. Participants will be pre-screened by telephone; those who appear to meet criteria will undergo further screening. The study will include baseline (0 month), 3 and 6 month visits for study procedures, and monthly telephone calls. Given that there is a visible difference between the two interventions, a blinded study is not possible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chickpeas/potatoes | Placebo comparator | Other: potato or chickpea1 potato/day or 1 cup chickpeas |
| avocados | Active comparator | Other: avocado1 avocados/day |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- men and women age > 50 years
- BMI 19-30 kg/m2
- lutein intake of < 3 mg/d
- Docosahexaenoic acid intake < 250 mg/d (including supplements)
- Mini mental state exam (MMSE) score > 24
Key exclusion criteria (17 listed)
- history of active small bowel disease or resection
- atrophic gastritis
- hyperlipidemia (LDL >120 mg/dL or triglycerides >150 mg/dL)
- hypertension (>150/90 mm Hg)
- diabetes, alcoholism (>2 drinks/d or 14 drinks/week)
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 |
|---|---|---|
| avocado1 avocado/day for 6 months | Other | avocados |
| potato or chickpea1 cup potatoes or chickpeas/day for 6 months | Other | chickpeas/potatoes |
Primary outcome
Cognition
Time frame: 6 months
measures of sustained attention will be made using CANTAB, a sensitive computerized program. Signal detection measured on a scale from 0 to 1(bad to good).
3 secondary outcomes
Inflammation
Time frame: 0 months
Inflammation
Time frame: 3 month
Inflammation
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Elizabeth J Johnson, Ph.D. principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing avocado and potato or chickpea in people with Mild Cognitive Impairment, run by Tufts University at 1 site in United States.
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 14 inclusion and 17 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cognition (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2019.