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

NCT05542199 | Completed DMC

• 1 other identifier: 2273
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition; Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Microvascular cerebral blood flow in fasting state

  Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization

• Microvascular cerebral blood flow in fed state

  Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization

• Macrovascular cerebral blood flow velocity in fasting state

  Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization

• Macrovascular cerebral blood flow velocity in fed state

  Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization

Other Outcomes (1)

• Weight loss

  Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization

Study Arms (4)

+MCNS+WL

ACTIVE COMPARATOR

This group receives the multicomponent nutrition supplement and the behavioral weight loss intervention.

Other: Multicomponent nutrition supplement (MCNS); Behavioral: Behavioral weight loss program

-MCNS+WL

PLACEBO COMPARATOR

This group receives the placebo nutrition supplement and the behavioral weight loss intervention.

Behavioral: Behavioral weight loss program

+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).

Other: Multicomponent nutrition supplement (MCNS)

-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)

Interventions

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.

+MCNS+WL; +MCNS-WL

Behavioral weight loss program BEHAVIORAL

Enrollment in behavioral weight loss intervention for 12 months modeled on the Diabetes Prevention Program.

+MCNS+WL; -MCNS+WL

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women and men aged 55-85 years.
• BMI of 27.0-39.9 kg/m2 at screening (higher BMIs not included at this time to facilitate program adherence);
• 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.
• 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.
• Has access to computer or smartphone with Wi-Fi and possesses a freezer at home with space for supplement storage.
• 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.
• Average energy intake in 3 24-h dietary recalls is within physiological (i.e., plausible) range.

You may not qualify if:

• \>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).
• 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.
• Does not like, or alternatively reports eating \>1 serving per week of \>60% chocolate or cocoa.
• 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.
• 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.
• Major psychiatric disorder history (schizophrenia, bipolar affective disorder, intractable depression).
• Inadequately controlled hypertension at the discretion of study MD or RN
• Diabetes Type 1 \& Type 2 or use of any pharmacological treatment for diabetes or HbA1c \>6.5 at screening.
• History of stomach or bowel resection (other than appendectomy), gastric bypass, or other bariatric weight loss procedure
• 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
• Chronic kidney disease or history of kidney stones
• History of diagnosed eating disorder anorexia, bulimia or binge-eating
• Active treatment for cancer (except non-melanoma skin cancer) of any type in ≤ 3 year.
• Thyroid disease or other significant endocrine disorder
• Uncontrolled hypercholesterolemia.

Sponsors & Collaborators

• Tufts University: lead
• Massachusetts General Hospital: collaborator
• University of Florida: collaborator
• University of New Hampshire: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan B. Roberts, Ph.D.

  Jean Mayer USDA Human Nutrition Research Center on Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: September 15, 2022
• Study Start: September 13, 2022
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: May 6, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 12 months of publication of the primary paper.

Locations

US (1)