Effect of Daily Mixed Spice Consumption on Memory Function

Effect of Daily Mixed Spice Consumption on Memory in Middle-Aged and Older Adults with Age-related Cognitive Decline: a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Function; Memory
• Intervention / Treatment: Dietary supplement: Mixed spices; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hila Zelicha, RD PHD; Phone Number: +1-310-206-8292; Email: uclanutrition@gmail.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • Recruiting
      • UCLA Center for Human Nutrition
      • Contact: Hila Zelicha; Phone Number: +1-310-206-8292; Email: uclanutrition@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 4.00 g maltodextrin capsules
Active Comparator: Mixed spices	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory	Verbal Episodic Memory (Rey Auditory Verbal Learning Test (RAVLT)-Revised, number of words correctly recalled after the long delay).	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month
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.	6 month
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).	6 month
Body weight	Body weight: Body weight will be measured at baseline, 6,12, and 24 weeks.	6 month
Body composition	Body composition: Body weight and composition analysis will be performed using the Tanita-BC418 body-fat analyzer (Tanita Corp., Tokyo, Japan) based on the principles of bioelectrical impedance at baseline, 6,12, and 24 weeks.	6 month
Sleep Quality	Sleep Quality, Pittsburgh Sleep Quality Index: PSQI will be employed to assess sleep quality. The PSQI is a widely recognized self-report questionnaire that evaluates sleep quality over a one-month interval. The PSQI comprises 19 self-rated items and an additional 5 items rated by bed partners or roommates. The self-rated items are used to calculate the total score, which ranges from 0 to 21. Each item on the PSQI is scored on a scale of 0 to 3, with 3 reflecting the highest level of dysfunction or disturbance. The scores of these items are then summed to compute a global PSQI score. A global PSQI score greater than 5 suggests significant sleep difficulties. A higher total score is indicative of poorer sleep quality.	6 month
24-hour Diet Recall	24-hour Diet Recall: Dietary energy and macronutrient intake will be assessed at baseline, 6,12, and 24 weeks during site visits. For the 24-hr dietary recall we will be using the Automated Self-Administered 24-hour Dietary Recall (ASA24™) tool (https://asa24.nci.nih.gov/).	6 month
Quality of life, SF-36	The SF-36 domain: Physical Functioning: Measures the ability to perform a range of physical activities without limitations, such as walking, climbing stairs, or carrying groceries.	6 month
Quality of life, SF-36	The SF-36 domain: Role-Physical: Assesses limitations in work or daily activities due to physical health problems.	6 month
Quality of life, SF-36	The SF-36 domain: Pain: Evaluates the impact of pain on daily activities and the extent of pain experienced.	6 month
Quality of life, SF-36	The SF-36 domain: General Health: Reflects overall health perceptions, including personal health outlook and resistance to illness.	6 month
Quality of life, SF-36	The SF-36 domain: Vitality: Captures energy levels and fatigue, distinguishing between feeling energetic versus feeling tired or worn out.	6 month
Quality of life, SF-36	The SF-36 domain: Social Functioning: Measures the impact of physical or emotional health on social activities and interactions with others.	6 month
Quality of life, SF-36	The SF-36 domain: Role-Emotional: Assesses the extent to which emotional problems interfere with work or other daily activities.	6 month
Quality of life, SF-36	The SF-36 domain: Mental Health: Evaluates psychological well-being, including feelings of depression, anxiety, and overall emotional stability.	6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood anti-oxidation capacity	Blood anti-oxidation capacity will be measured using Oxygen radical antioxidant capacity (ORAC) and trolox equivalent antioxidant capacity (TEAC) assays.	6 month
Plasma inflammatory panel	Plasma inflammatory panel will be measured using the Luminex MagPix® analyzer (Luminex, Austin TX)	6 month
Fecal microbiome	Fecal microbiome will be analyzed at UCLA microbiome core	6 month
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.	6 month

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Zhaoping Li, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): February 21, 2027
• Study Completion (Estimated): February 21, 2027

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 23-001878

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No