Effect of Daily Mixed Spice Consumption on Memory Function

NCT ID: NCT06889961

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-21
• Study Completion Date: 2027-02-21

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

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Mixed spices

Group Type: ACTIVE_COMPARATOR

Mixed spices

Intervention Type: 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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

4.00 g maltodextrin capsules

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

4.00 g maltodextrin capsules

Intervention Type: OTHER

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.

-

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Zhaoping Li

Professor of Medicine and Chief of the Division of Clinical Nutrition at the University of California, Los Angeles

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaoping Li

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Center for Human Nutrition

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hila Zelicha, RD PHD

Role: CONTACT

uclanutrition@gmail.com

+1-310-206-8292

Facility Contacts

Hila Zelicha

Role: primary

uclanutrition@gmail.com

+1-310-206-8292

Other Identifiers

23-001878

Identifier Type: -

Identifier Source: org_study_id