Turmeric extractControl: Placebo. 500mg gelatin in capsules 2 times a day
Turmeric extract: The intervention group includes aerobic exercise and cognitive exercise (grid mat), nutritional guidance, a healthy aging program, turmeric capsules, and black pepper
Control: Placebo. 500mg gelatin in capsules 2 times a day: The control group includes an aerobic exercise program and cognitive exercise (grid mat with various patterns of complexity, applied by a health professional), nutritional guidance, and healthy aging program, plus a placebo.
Study summary
Introduction: The Insulin resistance itself has been recognized as an independent risk factor for dementia development. Insulin plays an important role in the regulation of muscle function and the processes of learning and memory. Insulin resistance is associated with increased inflammation and oxidative stress. These processes are involved in the pathophysiology of neurodegenerative diseases. Thus, reducing IR could have implications for improving metabolism, muscle, and cognitive function.
Methods and analysis. The investigators will conduct a randomized, double-blind, placebo-controlled clinical trial in which a multidomain program, including an aerobic and cognitive exercise program, will be evaluated. The latter is an exercise program conducted on a checkered mat and will be randomized to participants receiving turmeric plus black pepper or placebo. Participants are affiliated with the Mexican Social Security Institute (IMSS) and are between 55 and 74 years old. The program will last for 24 weeks; after 52 weeks, it will be repeated. The outcomes that the investigators will evaluate are: global cognitive function, specific cognitive function, and the investigators will evaluate serum markers of inflammation, oxidative stress, and GSK-3beta levels. The effect of the interventions on each variable will be analyzed by ANOVA, and a multivariate analysis study with multiple linear regression will be conducted.
Ethics and dissemination of the study: the study was approved by the IMSS National Ethics and Research Committee all participants provided written informed consent prior to their participation.
Eligibility
Sex
ALL
Min age
55 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* Minimum Age: 55 Years Maximum Age: 70 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No Criteria: Inclusion criteria.
* 1\. With 55-70 years of age.
* 2\. They have self-reported cognitive concerns (ie, have answered "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?").
* 3\. The participant has insulin resistance measured with HOMA IR index \> 2.5.
* 4\. They demonstrate functional independence in activities of daily living and instrumental activities of daily living.
* 5\. They have symptoms or signs of underlying cognitive dysfunction without a diagnosis of dementia (ie, confirmed by a review of their health records and a Mini Mental State Exam \[MMSE\] score\> 24).
* 6\. If the participant are a woman, one year after having gone through menopause.
Exclusion Criteria:
* 1\. With depression (score\> 15 according to the Center for Epidemiological Studies Depression Scale - Revised \[CESD-R\]).
* 2\. With clinically significant neurological or psychiatric disorders (eg, Parkinson's, schizophrenia).
* 3\. With a recent severe cardiovascular event (eg, myocardial infarction, stroke).
* 4\. With a major orthopedic condition (eg, severe osteoarthritis).
* 5\. With blood pressure that is unsafe for exercise (ie,\> 180/100 mmHg or \<100/60 mmHg).
* 6\. With a severe visual or auditory impairment.
* 7\. With an unwillingness to adhere to the intervention schedules.
* 8\. Patients with active cancer, who are undergoing chemotherapy, radiotherapy, or other treatments aimed at eradicating cancer and who have been undergoing treatment during the last year.
* 9\. Elimination: participants with incomplete data and who have not complied with the intervention by 80%.
Primary outcome measure(s)
Improving insulin resistance by 5%. — 12, 24 y 52 weeks The investigadors will measure various parameters of insulin resistance such as glycated hemoglobin, insulin resistance index, and we will measure the improvement of these parameters.
General Cognitive funtion — Time Frame: 0, 24 and 52 weeks General cognitive function assessed by the Montreal Cognitive Assessment (MoCA) test on a scale of 0-30 points.
Scores are interpreted as follows: \>26 indicates no dementia, 18-26 mild cognitive impairment, 6-10 moderate dementia.
Specific domains of cognitive function — 0, 24, 52 weeks Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT), that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.
Oxidative stress. — 0, 12. 24. 52 weeks. The investigators will measure several parameters of oxidative stress, including 4-hydroxynonenal (4OH-N), malonaldehyde (MDA), quinones, and glutathione system activity.
Trial sites (1)
Facility
City
Region
Status
Centro Medico Nacional Siglo XXI, unidad de investigación en epidemiología y servicio de salud.
Mexico City
Cuauhtémoc
More Instituto Mexicano del Seguro Social trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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