Mediterranean Diet, Weight Loss, and Cognition in Obese Older Adults

NCT03129048 | Completed DMC

• 1 other identifier: 2016-0258
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The deleterious effects of obesity on cardiovascular disease (CVD) and metabolic risk factors (dyslipidemia, hypertension, and insulin resistance) are well-documented. Recent evidence also links obesity to cognitive decline and dementia. Dietary patterns are central to the development and maintenance of obesity and certain dietary patterns may contribute to the onset and progression of cognitive decline. With the rapid aging of the US population and the high prevalence of obesity among older adults, innovative lifestyle strategies to prevent cognitive decline among ethnically diverse obese older adults are critically needed.

Conditions

Cognition; Obese Older Adults; Mediterranean Diet

Outcome Measures

Primary Outcomes (3)

• Assessing change in Attention between time periods

  Baseline, 8-month (first intervention), and 14-month assessments will include Digit Symbol test.

  14 months

• Assessing change in Executive Function between time periods

  Baseline, 8-month (first intervention), and 14-month assessments will include the Trail Making Test Part B.

  14 months

• Assessing change in Memory between time periods

  Baseline, 8-month (first intervention), and 14-month assessments will include tests of memory including the delayed free recall from the Hopkins Verbal Learning Test.

  14 months

Study Arms (3)

MedDiet-WL

EXPERIMENTAL

MedDiet-WL group, advice and exchange lists will be designed to promote a 1-2 lb. per week weight loss (approximately 30% caloric restriction or a reduction of about 600 calories per day) for an end goal of a 7% weight loss from baseline.

Behavioral: MedDiet

MedDiet-A

EXPERIMENTAL

For the MedDiet-A group, dietary advice and corresponding exchange lists will be given within the context of promoting weight stability.

Behavioral: MedDiet

Typical Diet Control (TDC)

OTHER

Typical Diet Control (TDC) will maintain current eating and activity patterns and weight over 14 months.

Behavioral: MedDiet

Interventions

MedDiet BEHAVIORAL

Research subjects will be randomly assigned to one of three intervention groups. The MedDiet-A group will learn about and how to adhere to the Mediterranean Diet. Over the course of 8 months, they will receive twenty-two classes 60-minute in length. The MedDiet-WL group will learn about the Mediterranean Diet, how to adhere to is and engage in lifestyle choices like exercising and eating fewer calories so that they will loose weight. Over the course of 8 months they will receive 22 classes, each 90 minutes in length. The Typical Diet Control group will be asked to maintain current eating and activity patterns over the course of the 14 month study.

MedDiet-A; MedDiet-WL; Typical Diet Control (TDC)

Eligibility Criteria

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

You may qualify if:

• Men and women ≥ 55 years of age\],
• BMI 30.0-50.0 kg/m2,
• English speaking
• Have access to a phone
• Plan to reside in the Chicago area for the following 14 months
• Minimal levels of cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA) \< 19.

You may not qualify if:

• renal disease
• autoimmune disorder
• immunodeficiency
• malabsorptive disorder
• gastrointestinal and hepatic diseases
• severe ischemic heart disease
• severe pulmonary disease
• bariatric surgery
• alcohol abuse (\> 50 grams/day) or illicit drug abuse
• uncontrolled diabetes based on capillary hemoglobin A1c (HbA1c) \> 9.0%
• schizophrenia or bipolar disorder
• cancer treatment within the past 12 months
• weight \> 450 lbs. (due to the weight limitation of the DXA scanner)
• diagnosed sleep apnea and regularly using a cpap machine
• currently adhering to a MedDiet, Montreal Cognitive Assessment (MoCA) \< 19,(161) -

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University Of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Related Publications (2)

• Fitzgibbon M, Blumstein L, Schiffer L, Antonic MA, McLeod A, Dakers R, Restrepo L, Boots EA, Sanchez-Flack JC, Tussing-Humphreys L, Lamar M. Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial. Trials. 2021 Jul 16;22(1):459. doi: 10.1186/s13063-021-05383-6.

  PMID: 34271944 DERIVED

• Fitzgibbon M, Blumstein L, Schiffer L, Antonic MA, McLeod A, Dakers R, Restrepo L, Boots EA, Sanchez-Flack JC, Tussing-Humphreys L, Lamar M. Adapting to the impact of the COVID-19 pandemic on a randomized controlled trial examining lifestyle behaviors on cognitive functioning in obese African American adults: Building Research in Diet and Cognition (BRIDGE). Res Sq [Preprint]. 2021 Apr 26:rs.3.rs-290482. doi: 10.21203/rs.3.rs-290482/v1.

  PMID: 34013252 DERIVED

Study Officials

• Marian Fitzgibbon, PhD

  UIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Department of Pediatrics

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 26, 2017
• Study Start: September 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (1)