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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| University of Florida | OTHER |
| University of New Hampshire | OTHER |
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The goal of the trial is to determine the feasibility of implementing a specific nutrition regimen used alone or in combination with a behavioral weight loss (WL) intervention on cognition and cerebral blood flow in older adults at risk of cognitive decline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| +MCNS+WL | Active Comparator | This group receives the multicomponent nutrition supplement and the behavioral weight loss intervention. |
|
| -MCNS+WL | Placebo Comparator | This group receives the placebo nutrition supplement and the behavioral weight loss intervention. |
|
| +MCNS-WL | Active Comparator | This group receives the multicomponent nutrition supplement and is in the control group for the behavioral weight loss intervention (no behavioral intervention during the trial, but participant is wait-listed to receive one after the trial finishes). |
|
| -MCNS-WL | No Intervention | This group receives the placebo nutrition supplement and is in the control group for the behavioral weight loss intervention (no behavioral intervention during the trial, but participant is wait-listed to receive one after the trial finishes) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent nutrition supplement (MCNS) | Other | Palatable daily nutrition supplement for 12 months containing approximately 300 kcal and a wide range of nutrients and plant constituents with potential to support brain health and cognition. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | Change in age-sensitive cognitive composite z-score from baseline, based on well-established standardized scores on 5 neuropsychological tests (Controlled Oral; Word Association Test, Digit Symbol Substitution Test; Stroop Interference Test; Trails Making Tests A and B) | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Microvascular cerebral blood flow in fasting state | Change in microvascular cerebral blood flow from baseline, measured with diffuse correlation spectroscopy / near infrared spectroscopy during fasting state | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization |
| Microvascular cerebral blood flow in fed state |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Change in body weight from baseline | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization |
Major inclusion criteria:
Major exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan B. Roberts, Ph.D. | Jean Mayer USDA Human Nutrition Research Center on Aging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | Boston | Massachusetts | 02111 | United States |
De-identified data will be shared consistent with NIH policies.
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Within 12 months of publication of the primary paper.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 15, 2025 | |
| Reset | Oct 28, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 15, 2025 | Oct 28, 2025 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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A 2x2 factorial design in which participants are assigned to the multicomponent nutrition supplement or a placebo, and to participation in a behavioral weight loss intervention or to a wait-list control
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Masking occurs after randomization. Participants and investigators and outcome assessors are masked to the assignment to the nutritional supplement vs placebo. Investigators responsible for the weight loss intervention, and outcome assessors, are masked to the assignment to the behavioral weight loss intervention versus the wait-list control.
| Behavioral weight loss program | Behavioral | Enrollment in behavioral weight loss intervention for 12 months modeled on the Diabetes Prevention Program. |
|
Change in microvascular cerebral blood flow from baseline, measured with diffuse correlation spectroscopy / near infrared spectroscopy during fed state |
| Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization |
| Macrovascular cerebral blood flow velocity in fasting state | Change in macrovascular cerebral blood flow velocity measured with transcranial Doppler ultrasound measured during fasting state | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization |
| Macrovascular cerebral blood flow velocity in fed state | Change in macrovascular cerebral blood flow velocity measured with transcranial Doppler ultrasound measured during fed state | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |