Clinical trial NCT06889961: Effect of Daily Mixed Spice Consumption on Memory Function
Official title: Effect of Daily Mixed Spice Consumption on Memory in Middle-Aged and Older Adults with Age-related Cognitive Decline: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Memory
Cognitive Function
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aging process entails a multitude of structural and functional alterations within the brain, culminating in a gradual and progressive decline in cognitive function. Recent research has indicated that various spices may hold the key to enhancing brain health and combating the effects of aging on cognitive abilities. The hypothesis is that a mixture of spices, acknowledged for their reported memory protection potential, may yield a more potent beneficial effect on memory function than a single spice. The spice mixture will be used at culinary dose, and therefore side effects are anticipated. In this study, the effects of spice mixture will be evaluated, as well as their anti-oxidant, and anti-inflammatory properties. The proposed pilot study will include 50 adults (ages 50-80), exhibiting typical age-related mild cognitive decline, excluding dementia or major neurocognitive disorders. They will be randomized 1:1 assigned into a daily intake of either 4.00 g spice mixture capsules or 4.00 g maltodextrin capsules over 3 months, and explore the sustainable effect over 3 additional months. The changes in symptoms of cognition, fatigue, and mood symptoms of the spice group vs. placebo group will be compared. The outcome of the investigation of the effects of mixed spice consumption will provide important novel information on dietary recommendation of spice to preserve cognitive function in aging population.


Eligibility criteria: Inclusion Criteria:

1. Participants are required to have clinical histories consistent with normal aging or mild cognitive impairment (MCI).
2. Age 50 to 80 years.
3. Adequate visual acuity and hearing to allow neuropsychological testing.
4. Screening laboratory tests without significant abnormalities that might interfere with the study.

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Exclusion Criteria:

1. Diagnosis of probable Alzheimer's disease or any other dementia (e.g. vascular, Lewy body, frontotemporal)
2. Evidence of other neurological or physical illness that can produce cognitive deterioration. Determination of dementia will be based on the clinical evaluation including assessment of functional abilities, and cognitive screening (using the Mini Mental State Examination
3. Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale \[38\].
4. Uncontrolled hypertension (systolic blood pressure (BP) \> 170 or diastolic BP \> 100).
5. Consume spices regularly \> 5g day
6. Allergy or sensitivity to spices. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive history of spices ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded.
7. Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
8. Current diagnosis or alcoholism or substance addiction.
9. Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
10. Frequently using prebiotics, probiotics, yogurt, and/or any fiber supplements

Primary outcomes:
measure: Memory
timeFrame: 6 month
Secondary outcomes:
measure: Executive Function
timeFrame: 6 month
measure: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory
timeFrame: 6 month
measure: Fatigue
timeFrame: 6 month
measure: Body weight
timeFrame: 6 month
measure: Body composition
timeFrame: 6 month
measure: Sleep Quality
timeFrame: 6 month
measure: 24-hour Diet Recall
timeFrame: 6 month
measure: Quality of life, SF-36
timeFrame: 6 month
measure: Quality of life, SF-36
timeFrame: 6 month
measure: Quality of life, SF-36
timeFrame: 6 month
measure: Quality of life, SF-36
timeFrame: 6 month
measure: Quality of life, SF-36
timeFrame: 6 month
measure: Quality of life, SF-36
timeFrame: 6 month
measure: Quality of life, SF-36
timeFrame: 6 month
measure: Quality of life, SF-36
timeFrame: 6 month
Other outcomes:
measure: Blood anti-oxidation capacity
timeFrame: 6 month
measure: Plasma inflammatory panel
timeFrame: 6 month
measure: Fecal microbiome
timeFrame: 6 month
measure: Mitochondrial function
timeFrame: 6 month
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Zhaoping Li
role: PRINCIPAL_INVESTIGATOR
References: