Recruiting

Mixed Spice Capsules for Memory in Age-related Cognitive Decline

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Mixed spices

+ Placebo
Dietary Supplement
Other
Who is being recruted

Memory

+ Cognitive Function
From 50 to 80 Years
+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: February 2025

See protocol details

Summary

Principal SponsorUniversity of California, Los Angeles
Study ContactHila Zelicha, RD PHD
Last updated: March 21, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: February 21, 2025Actual date on which the first participant was enrolled.

This study investigates whether consuming a mix of spices can improve memory in middle-aged and older adults experiencing normal age-related memory decline. As people age, changes in the brain can lead to slower thinking and memory issues. Some spices are thought to help protect memory, and this study explores if a combination of these spices is more effective than using just one. The study aims to find out if regular intake of these spices can help maintain brain health and support better memory, potentially offering new dietary advice for older adults. Participants in the study are between 50 and 80 years old and do not have dementia or major memory disorders. They are randomly assigned to take either spice capsules or placebo capsules made of maltodextrin for three months, followed by an additional three-month observation period. The study measures changes in memory, energy levels, and mood to see if the spice mixture has any impact. By evaluating antioxidant and anti-inflammatory properties of the spices, this research seeks to provide insights into how spices might help preserve cognitive function in aging populations.

Official TitleEffect of Daily Mixed Spice Consumption on Memory in Middle-Aged and Older Adults with Age-related Cognitive Decline: a Pilot Study 
Principal SponsorUniversity of California, Los Angeles
Study ContactHila Zelicha, RD PHD
Last updated: March 21, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 50 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Memory
Cognitive Function
Criteria
4 inclusion criteria required to participate
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
10 exclusion criteria prevent from participating
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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Active Comparator
Group II
Placebo
Study Objectives
Primary Objectives

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

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.

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.

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).

Body weight: Body weight will be measured at baseline, 6,12, and 24 weeks.

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.

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.

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/).

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.

The SF-36 domain: Role-Physical: Assesses limitations in work or daily activities due to physical health problems.

The SF-36 domain: Pain: Evaluates the impact of pain on daily activities and the extent of pain experienced.

The SF-36 domain: General Health: Reflects overall health perceptions, including personal health outlook and resistance to illness.

The SF-36 domain: Vitality: Captures energy levels and fatigue, distinguishing between feeling energetic versus feeling tired or worn out.

The SF-36 domain: Social Functioning: Measures the impact of physical or emotional health on social activities and interactions with others.

The SF-36 domain: Role-Emotional: Assesses the extent to which emotional problems interfere with work or other daily activities.

The SF-36 domain: Mental Health: Evaluates psychological well-being, including feelings of depression, anxiety, and overall emotional stability.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
UCLA Center for Human NutritionLos Angeles, United StatesSee the location
Recruiting
One Study Center