Effect of Daily Mixed Spice Consumption on Memory Function

NCT06889961 | Recruiting

• 1 other identifier: 23-001878
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Memory

  Verbal Episodic Memory (Rey Auditory Verbal Learning Test (RAVLT)-Revised, number of words correctly recalled after the long delay).

  6 month

Secondary Outcomes (15)

• Executive Function

  6 month

• Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory

  6 month

• Fatigue

  6 month

• Body weight

  6 month

• Body composition

  6 month

Other Outcomes (4)

• Blood anti-oxidation capacity

  6 month

• Plasma inflammatory panel

  6 month

• Fecal microbiome

  6 month

Study Arms (2)

Mixed spices

ACTIVE COMPARATOR

Dietary Supplement: Mixed spices

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Mixed spices DIETARY_SUPPLEMENT

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

Mixed spices

Placebo OTHER

4.00 g maltodextrin capsules

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

RECRUITING

Study Officials

• Zhaoping Li

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hila Zelicha, RD PHD

CONTACT

+1-310-206-8292; uclanutrition@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Chief of the Division of Clinical Nutrition at the University of California, Los Angeles

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 21, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): February 21, 2027
• Study Completion (Estimated): February 21, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

US (1)