Effect of Daily Mixed Spice Consumption on Memory Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mixed spices, Placebo.
- Who it may be relevant to
- Registry conditions: Memory, Cognitive Function. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Daily Mixed Spice Consumption on Memory in Middle-Aged and Older Adults With Age-related Cognitive Decline: A Pilot Study
Overview
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.
Interventions
- Dietary supplement Mixed spices
Mixed 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 - Other Placebo
4.00 g maltodextrin capsules
Primary outcome measures
- Memory [Time frame: 6 month]
Secondary outcome measures (12)
- Executive Function [Time frame: 6 month]
- Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory [Time frame: 6 month]
- Fatigue [Time frame: 6 month]
- Body weight [Time frame: 6 month]
- Body composition [Time frame: 6 month]
- Sleep Quality [Time frame: 6 month]
- 24-hour Diet Recall [Time frame: 6 month]
- Quality of life, SF-36 [Time frame: 6 month]
- Quality of life, SF-36 [Time frame: 6 month]
- Quality of life, SF-36 [Time frame: 6 month]
- Quality of life, SF-36 [Time frame: 6 month]
- Quality of life, SF-36 [Time frame: 6 month]
Eligibility criteria
Inclusion criteria
- 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.
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Exclusion criteria
- 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).
- Consume spices regularly > 5g day
- 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.
- Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
- Current diagnosis or alcoholism or substance addiction.
- Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
- Frequently using prebiotics, probiotics, yogurt, and/or any fiber supplements
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UCLA Center for Human Nutrition — Los Angeles
Identifiers
NCT: NCT06889961 · 23-001878