UCLA Center for Human Nutrition
Los Angeles, California, 90024, United States
Location status: Recruiting
NCT Number: NCT06889961
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90024, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
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
4.00 g maltodextrin capsules
Time frame: 6 month
Verbal Episodic Memory (Rey Auditory Verbal Learning Test (RAVLT)-Revised, number of words correctly recalled after the long delay).
Time frame: 6 month
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.
Time frame: 6 month
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.
Time frame: 6 month
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).
Time frame: 6 month
Body weight: Body weight will be measured at baseline, 6,12, and 24 weeks.
Time frame: 6 month
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.
Time frame: 6 month
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.
Time frame: 6 month
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/).
Time frame: 6 month
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.
Time frame: 6 month
The SF-36 domain:
Role-Physical: Assesses limitations in work or daily activities due to physical health problems.
Time frame: 6 month
The SF-36 domain:
Pain: Evaluates the impact of pain on daily activities and the extent of pain experienced.
Time frame: 6 month
The SF-36 domain:
General Health: Reflects overall health perceptions, including personal health outlook and resistance to illness.
Time frame: 6 month
The SF-36 domain:
Vitality: Captures energy levels and fatigue, distinguishing between feeling energetic versus feeling tired or worn out.
Time frame: 6 month
The SF-36 domain:
Social Functioning: Measures the impact of physical or emotional health on social activities and interactions with others.
Time frame: 6 month
The SF-36 domain:
Role-Emotional: Assesses the extent to which emotional problems interfere with work or other daily activities.
Time frame: 6 month
The SF-36 domain:
Mental Health: Evaluates psychological well-being, including feelings of depression, anxiety, and overall emotional stability.
Time frame: 6 month
Blood anti-oxidation capacity will be measured using Oxygen radical antioxidant capacity (ORAC) and trolox equivalent antioxidant capacity (TEAC) assays.
Time frame: 6 month
Plasma inflammatory panel will be measured using the Luminex MagPix® analyzer (Luminex, Austin TX)
Time frame: 6 month
Fecal microbiome will be analyzed at UCLA microbiome core
Time frame: 6 month
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.
Contact information is provided by the study sponsor or research team.
University of California, Los Angeles
Other
Effect of Daily Mixed Spice Consumption on Memory in Middle-Aged and Older Adults With Age-related Cognitive Decline: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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