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

Tufts University1 site in 1 country25 target enrollmentSeptember 13, 2022

ConditionsCognition Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cognition
Sponsor: Tufts University
Enrollment: 25
Locations: 1
Primary Endpoint: Cognitive function
Status: Completed
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 13, 2022

End Date

February 23, 2024

Last Updated

12 months ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Tufts University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Cognitive function

Time Frame: 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 Outcomes

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 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)