Clinical trial NCT05542199: Nutrition for Brain and Body Health (BB-Health) Feasibility Trial
Official title: Food Supplement Approach for Prevention of Age-associated Cognitive Decline in Older Adults With Obesity: the Nutrition for Brain and Body Health (BB-Health) Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Obesity
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: University of Florida
name: University of New Hampshire
First posted: 2022-09-15
Enrollment: 25
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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
Primary purpose: PREVENTION

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.


Eligibility 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 exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol. This includes the lost of smell or taste.
10. History of stomach or bowel resection (other than appendectomy), gastric bypass, or other bariatric weight loss procedure
11. GI diseases, conditions or meds known to influence GI absorption including active peptic ulcer disease or inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), Celiac disease, Cystic Fibrosis, malabsorption disorders, gallbladder disease, acute or chronic pancreatitis or Pancreatic insufficiency
12. Chronic kidney disease or history of kidney stones
13. History of diagnosed eating disorder anorexia, bulimia or binge-eating
14. Active treatment for cancer (except non-melanoma skin cancer) of any type in ≤ 3 year.
15. Thyroid disease or other significant endocrine disorder
16. Uncontrolled hypercholesterolemia.
17. History of acute or chronic pancreatitis or gall bladder disease.
18. Metabolic disorders or conditions that interfere with nutrient absorption (such as Phenylketonuria, Maple Syrup Urine Disease, glucose-galactose malabsorption, ornithine transcarbamylase deficiency or hypophosphatemic rickets.)
19. Dose adjustment to statin or antihypertensive medication within the past 3 months
20. Screening lab results outside the normal parameters that may interfere with study outcomes at the discretion of study MD
21. Inadequate venous access or history of a bilateral mastectomy with nodal dissection
22. Recent history of inflammatory diseases (for example: rheumatoid arthritis, lupus)
23. Active WL, or weight change \> 4 kg in past 6 months.
24. Consuming a restrictive diet (e.g. gluten-free, vegan, Paleolithic diet).
25. Self-reported allergy to any ingredient in the provided intervention foods.
26. Self-reported severe allergy to adhesives.
27. Unwilling to use a mobile phone or computer with videoconference software to participate in intervention group meetings. Unwilling to eat on camera.
28. Reports of consumption of \> 2 alcoholic drinks per day on average or \>14/week (168oz beer/56oz wine/14oz hard liquor.)
29. Reports of consumption of \> 2 cups of green or black tea per day on average.
30. Reports of use of recreational and/or illegal drugs.
31. Regular smoking or vaping tobacco or marijuana including the use of edibles within the last 6 months (greater than once a week)
32. Non-English speakers.
33. No social security number (required for stipend payment).

Primary outcomes:
measure: Cognitive function
timeFrame: Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
Secondary outcomes:
measure: Microvascular cerebral blood flow in fasting state
timeFrame: Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
measure: Microvascular cerebral blood flow in fed state
timeFrame: Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
measure: Macrovascular cerebral blood flow velocity in fasting state
timeFrame: Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
measure: Macrovascular cerebral blood flow velocity in fed state
timeFrame: Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
Other outcomes:
measure: Weight loss
timeFrame: Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Jean Mayer USDA Human Nutrition Research Center on Aging
name: Susan B. Roberts, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: