Effect of Daily Mixed Spice Consumption on Memory Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUniversity of California, Los Angeles
About this trial
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
This trial accepts healthy volunteersQualifiers
Participants are required to have clinical histories consistent with normal aging or mild cognitive impairment (MCI).
Age 50 to 80 years.
Adequate visual acuity and hearing to allow neuropsychological testing.
Screening laboratory tests without significant abnormalities that might interfere with the study.
Disqualifiers
Diagnosis of probable Alzheimer's disease or any other dementia (e.g. vascular, Lewy body, frontotemporal)
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
Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale [38].
Uncontrolled hypertension (systolic blood pressure (BP) > 170 or diastolic BP > 100).
Trial design
Design model
Parallel
Treatments tested in this trial
Mixed spices
Dietary supplementMixed spices 4.00 g capsules of spice mixture contain 1.0 g (25%) turmeric, 1.5 g (37.5%) cinnamon, 0.5 g (12.5%) oregano, 0.5 g (12.5%) black pepper, 0.3 g (7.5%) sage and 0.2 (5%) thyme
Placebo
Other intervention4.00 g maltodextrin capsules
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Mixed spicesActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Memory
Verbal Episodic Memory (Rey Auditory Verbal Learning Test (RAVLT)-Revised, number of words correctly recalled after the long delay).
Time frame
6 monthSecondary outcomes
1
Executive Function
These will be measured by Trailmaking part B (time/seconds) and Wechsler Adult Intelligence Scale Version IV (WAIS-IV), DVT (Digit Span Backwards). The length of the battery is approximately 15 minutes.
Time frame
6 month2
Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory
Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory will also be evaluated by The NIH Toolbox Cognition Battery (NIHTB-CB) It can be administered via computer, paper and pencil, and most recently, ipad platforms (45 mins). We will analyze, as a secondary outcome measure, the Crystallized Intelligence index.
Time frame
6 month3
Fatigue
Fatigue (as assessed by PROMIS-Fatigue Scale, Short Form 8 items): The NIH developed Patient Reported Outcomes Measurement Information System (PROMIS®). The PROMIS Fatigue scale assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The fatigue short forms are universal rather than disease-specific and assess fatigue over the past seven days (5 minutes).
Time frame
6 month4
Body weight
Body weight: Body weight will be measured at baseline, 6,12, and 24 weeks.
Time frame
6 monthOther outcomes
1
Blood anti-oxidation capacity
Blood anti-oxidation capacity will be measured using Oxygen radical antioxidant capacity (ORAC) and trolox equivalent antioxidant capacity (TEAC) assays.
Time frame
6 month2
Plasma inflammatory panel
Plasma inflammatory panel will be measured using the Luminex MagPix® analyzer (Luminex, Austin TX)
Time frame
6 month3
Fecal microbiome
Fecal microbiome will be analyzed at UCLA microbiome core
Time frame
6 month4
Mitochondrial function
Mitochondrial function as well as aging markers will be evaluated using blood samples at the UCLA Mitochondrial Metabolism core and Center for Human Nutrition Analytical Laboratory.
Time frame
6 monthSponsors and contacts
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Source ClinicalTrials.gov