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Sponsor withdrew.
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An estimated 50% of older adults complain of memory changes that worsen as they age. Although numerous commercially available dietary supplements claim cognitive benefits, relatively few well-designed, longitudinal, placebo-controlled studies have rigorously evaluated their effects on cognitive performance.
In a previous double-blind, randomized, placebo-controlled, 18-month clinical trial in middle-aged and older non-demented adults, the investigators found that a bioavailable form of curcumin taken orally twice a day showed greater gains on specific measures of memory and attention relative to placebo. Although the investigators found significant between-group curcumin/placebo differences with moderate effect sizes, the sample size (n=40) was small. The present adequately powered, randomized, double-blind, placebo-controlled study will evaluate the effect of daily consumption of bioavailable curcumin on measurable changes in cognitive performance in non-demented middle-aged and older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theracurmin Super TS-P1 capsules containing 75 mg in total of curcumin will be administered orally) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Dietary Supplement | Theracurmin Super TS-P1 capsules containing 75 mg in total of curcumin will be administered orally (swallowed with water) twice a day (during breakfast and dinner) for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Memory | The primary endpoint will be a memory domain score calculated from the Consistent Long Term Recall score of the Buschke Selective Reminding Test (SRT) | 12 months |
| Memory | Delayed Recall score of the Brief Visual Memory Test-Revised (BVMT-R). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function test | NIH TOOLBOX computerized set of cognitive tests | 12 months |
| PROMIS Cognitive Function | Short Form 20a is a standardized questionnaire designed to assess an individual's self-reported cognitive abilities and problems over the past 7 days. It includes 20 items and is part of the Patient-Reported Outcomes Measure. The instrument produces a T-score standardized to the PROMIS metric. T-scores typically range from 20 to 80, with a population mean of 50 and standard deviation of 10. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li | University of California, Los Angeles | Principal Investigator |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| Placebo | Other | Placebo |
|
| 12 months |
| Self-reported depression symptoms | Measured by Beck Depression Inventory (BDI). A 21-item self-report questionnaire assessing the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression (i.e., a worse outcome). | 12 months |
| Blood levels of curcumin | (to ensure adherence to protocol) | 12 months |
| Inflammation and neurodegenerative markers | such as, TNF-α, C-reactive protein | 12 months |
| metabolic markers | such as fasting glucose, insulin, C-peptide, glucagon, glucose-dependent-insulinotropic-polypeptide (GIP), HbA1C, and HOMA-IR index and lipid markers | 12 months |
| Quality of life | Quality of life, SF-36: The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. It measures each of the following eight health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health (about 15 minutes). | 12 months |
| Body composition | Body composition will be assessed using an InBody bioelectrical impedance analysis (BIA) device. | 12 months |
| APOE-4 carrier status | APOE-4 carrier status will be determined through genetic testing to identify whether participants possess at least one copy of the APOE 4 allele, a genetic risk factor associated with Alzheimer's disease. | 12 months |
| 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. | 12 months |
| Fatigue | Fatigue (as assessed by PROMIS-Fatigue Scale, Short Form 8 items): The NIH developed the Patient Reported Outcomes Measurement Information System (PROMIS®). The PROMIS Fatigue scale assesses 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). | 12 months |
| The Trail Making Test (TMT) | The Trail Making Test (TMT) is one of the most popular neuropsychological tests and is included in most test batteries. The TMT provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. | 12 months |
| Verbal Fluency Test | The Verbal Fluency Test, consisting of the FAS, PRW, and CFL phonemic fluency subtests, will be administered across three distinct time points to reduce practice effects and to allow for a more reliable assessment of longitudinal change in executive function and lexical retrieval. Administering different letter sets at each visit minimizes familiarity with specific stimuli and provides a more valid evaluation of verbal generativity and cognitive flexibility over time. | 12 months |
| Category Fluency Test | The Category Fluency Test, including the Animal Naming, Fruits and Vegetables Naming, and Cities and Towns Naming subtests, will be administered across three time points to assess semantic fluency while minimizing practice effects. Using a different semantic category at each visit reduces familiarity with specific item sets and provides a more accurate longitudinal measure of semantic memory retrieval, lexical access, and executive functioning. | 12 months |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |