Nutrition for Brain and Body Health (BB-Health) Feasibility Trial

Last updated: May 1, 2025
Sponsor: Tufts University
Overall Status: Completed

Phase

N/A

Condition

Obesity

Diabetes Prevention

Brain Function

Treatment

Behavioral weight loss program

Multicomponent nutrition supplement (MCNS)

Clinical Study ID

NCT05542199
2273
  • Ages 55-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

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 tofacilitate 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 thatparticipants can give consent and adhere to the study requirements, including theoutcomes testing.

  4. Willing to be randomized and participate in all study components, includingconsuming the foods and supplements, participating in the WL intervention or controlmeetings, being available for outcome assessments, using the provided home Wi-Fiscale and activity monitor daily, and completing questionnaires, as well asproviding the login information for scales and activity monitor so investigators candownload the data.

  5. Satisfactory screening review of health history questionnaire by nursing staff forrelevant factors including no evidence of exclusions listed below. This will includeverbal confirmation of completing a course of vaccination against COVID-19 (twodoses plus one booster prior to screening visit). The reason for this studycomponent is that live group meetings are planned with other participants, and thiswill reduce participant risk.

  6. Has access to computer or smartphone with Wi-Fi and possesses a freezer at home withspace for supplement storage.

  7. Rates representative food with characteristics of the MCNS and control foods atleast 4 on a 5-point scale of liking at screening, and reports that they are willingto consume the food daily.

  8. Average energy intake in 3 24-h dietary recalls is within physiological (i.e.,plausible) range.

Exclusion

Major exclusion criteria:

  1. >25% percentile in most recent data for US adult population intake for reportedDHA/EPA in screening questionnaire for rich food sources, which is equivalent to 2or more servings of fatty fish/month (86, 87).

  2. Regularly taking a multivitamin, cacao/cocoa supplement, choline supplement, DHA/EPAsupplement, 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% chocolateor cocoa.

  4. Severe cardiovascular disease including stroke, heart failure, coronary bypass andvalve replacement, coronary bypass or any surgical procedures or signs and symptomsof current severe cardiovascular disease.

  5. History of neurological brain disease, including stroke, seizure disorders,traumatic brain injury (moderate to severe); including prior diagnosis of aneurodegenerative disease including AD and Parkinson's disease, frontotemporaldementia. Moderate traumatic brain injury is defined by an injury with loss ofconsciousness.

  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 orHbA1c >6.5 at screening.

  9. Any disorder, unwillingness, or inability, not covered by any of the other exclusioncriteria, which in the investigator's opinion, might jeopardize the subject's safetyor compliance with the protocol. This includes the lost of smell or taste.

  10. History of stomach or bowel resection (other than appendectomy), gastric bypass, orother bariatric weight loss procedure

  11. GI diseases, conditions or meds known to influence GI absorption including activepeptic 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 ≤ 3year.

  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 asPhenylketonuria, 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 studyoutcomes 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 toparticipate in intervention group meetings. Unwilling to eat on camera.

  28. Reports of consumption of > 2 alcoholic drinks per day on average or >14/week (168ozbeer/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 withinthe last 6 months (greater than once a week)

  32. Non-English speakers.

  33. No social security number (required for stipend payment).

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Behavioral weight loss program
Phase:
Study Start date:
September 13, 2022
Estimated Completion Date:
February 23, 2024

Connect with a study center

  • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

    Boston, Massachusetts 02111
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.