Consumption of Potatoes, Avocados and Chickpeas and Cognitive Function in Older Adults

• Sponsor: Tufts University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01620567
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Other: avocado; Other: potato or chickpea	N/A

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

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Consumption of Potatoes, Avocados and Chickpeas Daily for 6 Months on Cognitive Function in Older Adults
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: chickpeas/potatoes 1 potato/day or 1 cup chickpeas	Other: potato or chickpea; 1 cup potatoes or chickpeas/day for 6 months
Active Comparator: avocados 1 avocados/day	Other: avocado; 1 avocado/day for 6 months

Outcome Measures

Primary Outcome Measures

1. Cognition [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).

Secondary Outcome Measures

1. Inflammation [0 months]

   C-reactive protein

2. Inflammation [3 month]

   C-reactive protein

3. Inflammation [6 month]

   C-reactive protein

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

• 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).

Exclusion Criteria:

• 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

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts University

Investigators

• Principal Investigator: Elizabeth J Johnson, Ph.D., Tufts University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tufts University
• ClinicalTrials.gov Identifier: NCT01620567
• Other Study ID Numbers: 002
• First Posted: Jun 15, 2012
• Last Update Posted: Jul 19, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tufts University: lutein; avocados; chickpeas; potatoes; elderly
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

Participant Flow

Arm/Group Title	Chickpeas/Potatoes	Avocados
Arm/Group Description	1 cup of chickpeas/potatoes for 6 months	1 avocado/day for 6 months
Period Title: Overall Study
STARTED	23	25
COMPLETED	20	20
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Chickpeas/Potatoes	Avocados	Total
Arm/Group Description	1 cup chickpeas/potatoes for 6 months	1 avocado/day for 6 months	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 75%	12 60%	27 67.5%
>=65 years	5 25%	8 40%	13 32.5%
Sex: Female, Male (Count of Participants)
Female	11 55%	13 65%	24 60%
Male	9 45%	7 35%	16 40%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 5%	0 0%	1 2.5%
Asian	0 0%	1 5%	1 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 20%	5 25%	9 22.5%
White	14 70%	13 65%	27 67.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 5%	1 5%	2 5%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Cognition
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chickpeas/Potatoes	Avocados
Arm/Group Description	1 potato/day or 1 cup chickpeas for 6 months	1 avocado/day for 6 months
Measure Participants	20	20
baseline - rapid visual information processing	.90 (.05)	.86 (.21)
3 mo - rapid visual information processing	.92 (.05)	.92 (.04)
6 mo - rapid visual information processing	.92 (.05)	.93 (.04)

2. Secondary Outcome

Title	Inflammation
Description	C-reactive protein
Time Frame	0 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chickpeas/Potatoes	Avocados
Arm/Group Description	1 potato/day or 1 cup chickpeas potato or chickpea: 1 cup potatoes or chickpeas/day for 6 months	1 avocados/day avocado: 1 avocado/day for 6 months
Measure Participants	20	20
Mean (Standard Deviation) [mg/L]	1.3 (1.0)	2.0 (2.8)

3. Secondary Outcome

Title	Inflammation
Description	C-reactive protein
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chickpeas/Potatoes	Avocados
Arm/Group Description	1 cup of chickpeas/potatoes for 6 months	1 avocado/day for 6 months
Measure Participants	20	20
Mean (Standard Deviation) [mg/L]	2.3 (2.4)	2.0 (2.8)

4. Secondary Outcome

Title	Inflammation
Description	C-reactive protein
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chickpeas/Potatoes	Avocados
Arm/Group Description	1 cup of chickpeas/potatoes for 6 months	1 avocado/day for 6 months
Measure Participants	20	20
Mean (Standard Deviation) [mg/L]	1.6 (1.6)	1.7 (1.8)

Adverse Events

Arm/Group Title	Chickpeas/Potatoes		Avocados
Arm/Group Description	1 cup chickpeas/potatoes for 6 months		avocados 1 avocado/day for 6 months
All Cause Mortality
	Chickpeas/Potatoes		Avocados
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/25 (0%)
Serious Adverse Events
	Chickpeas/Potatoes		Avocados
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Chickpeas/Potatoes		Avocados
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.