Cognition, Obesity
Conditions
Brief summary
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.
Interventions
OTHERMulticomponent nutrition supplement (MCNS)
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.
BEHAVIORALBehavioral weight loss program
Enrollment in behavioral weight loss intervention for 12 months modeled on the Diabetes Prevention Program.
Sponsors
Massachusetts General Hospital
University of Florida
University of New Hampshire
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Major inclusion criteria: 1. Adult women and men aged 55-85 years. 2. BMI of 27.0-39.9 kg/m2 at screening (higher BMIs not included at this time to facilitate program adherence); 3. Scores of 34 or greater on the Modified Telephone Interview for Cognitive Status (TICS-M) at screening (85). The purpose of this screen is to ensure that participants can give consent and adhere to the study requirements, including the outcomes testing. 4. Willing to be randomized and participate in all study components, including consuming the foods and supplements, participating in the WL intervention or control meetings, being available for outcome assessments, using the provided home Wi-Fi scale and activity monitor daily, and completing questionnaires, as well as providing the login information for scales and activity monitor so investigators can download the data. 5. Satisfactory screening review of health history questionnaire by nursing staff for relevant factors including no evidence of exclusions listed below. This will include verbal confirmation of completing a course of vaccination against COVID-19 (two doses plus one booster prior to screening visit). The reason for this study component is that live group meetings are planned with other participants, and this will reduce participant risk. 6. Has access to computer or smartphone with Wi-Fi and possesses a freezer at home with space for supplement storage. 7. Rates representative food with characteristics of the MCNS and control foods at least 4 on a 5-point scale of liking at screening, and reports that they are willing to consume the food daily. 8. Average energy intake in 3 24-h dietary recalls is within physiological (i.e., plausible) range. Major
Exclusion criteria
1. \>25% percentile in most recent data for US adult population intake for reported DHA/EPA in screening questionnaire for rich food sources, which is equivalent to 2 or more servings of fatty fish/month (86, 87). 2. Regularly taking a multivitamin, cacao/cocoa supplement, choline supplement, DHA/EPA supplement, or any supplement advertised for brain health or cognitive function (\>1/week). Washout period of 2 months accepted. 3. Does not like, or alternatively reports eating \>1 serving per week of \>60% chocolate or cocoa. 4. Severe cardiovascular disease including stroke, heart failure, coronary bypass and valve replacement, coronary bypass or any surgical procedures or signs and symptoms of current severe cardiovascular disease. 5. History of neurological brain disease, including stroke, seizure disorders, traumatic brain injury (moderate to severe); including prior diagnosis of a neurodegenerative disease including AD and Parkinson's disease, frontotemporal dementia. Moderate traumatic brain injury is defined by an injury with loss of consciousness. 6. Major psychiatric disorder history (schizophrenia, bipolar affective disorder, intractable depression). 7. Inadequately controlled hypertension at the discretion of study MD or RN 8. Diabetes Type 1 & Type 2 or use of any pharmacological treatment for diabetes or HbA1c \>6.5 at screening. 9. Any disorder, unwillingness, or inability, not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular cerebral blood flow in fasting state | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization | Change in microvascular cerebral blood flow from baseline, measured with diffuse correlation spectroscopy / near infrared spectroscopy during fasting state |
| Microvascular cerebral blood flow in fed state | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization | Change in microvascular cerebral blood flow from baseline, measured with diffuse correlation spectroscopy / near infrared spectroscopy during fed state |
| Macrovascular cerebral blood flow velocity in fasting state | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization | Change in macrovascular cerebral blood flow velocity measured with transcranial Doppler ultrasound measured during fasting state |
| Macrovascular cerebral blood flow velocity in fed state | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization | Change in macrovascular cerebral blood flow velocity measured with transcranial Doppler ultrasound measured during fed state |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization | Change in body weight from baseline |
Countries
United States
Outcome results
None listed