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

Not Applicable

Recruiting

• Conditions: Cognition; Obesity
• Interventions: Other: Multicomponent nutrition supplement (MCNS); Behavioral: Behavioral weight loss program

• Registration Number: NCT05542199
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Status Verified: 2022-09
• Study Start: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
+MCNS+WL	Behavioral weight loss program	This group receives the multicomponent nutrition supplement and the behavioral weight loss intervention.
-MCNS+WL	Behavioral weight loss program	This group receives the placebo nutrition supplement and the behavioral weight loss intervention.
+MCNS-WL	Multicomponent nutrition supplement (MCNS)	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).
+MCNS+WL	Multicomponent nutrition supplement (MCNS)	This group receives the multicomponent nutrition supplement and the behavioral weight loss intervention.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States