Mediterranean Diet, Weight Loss, and Cognition in Obese Older Adults
6. april 2021 opdateret af: Dr. Fitzgibbon, University of Illinois at Chicago
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Obesity is a leading cause of death and disability in the United States, affecting as many as 80 million Americans.
It is well-established that obesity contributes to a number of risk factors for metabolic abnormalities and cardiovascular diseases (CVD), including hypertension, diabetes, and hyperlipidemia.
In addition, there is growing evidence that obesity is associated with cognitive deficits in multiple domains, even in otherwise healthy older adults.
With the rapidly aging US population and the high prevalence of obesity among older adults, innovative strategies to prevent cognitive decline in this population are needed.
Dietary patterns are central to the development and maintenance of obesity and evidence suggests that dietary factors also may affect cognition.
Studies have shown that adherence to a Mediterranean Diet (MedDiet) is associated with less cognitive decline and reduced risk for dementia in older adults.
Weight loss through caloric restriction also has been shown to improve cognitive function in obese adults.
Both the MedDiet and weight loss are thought to improve cognition in obese individuals and reduce CVD/metabolic risk through beneficial changes in systemic inflammation and oxidative stress.
The identification of effective lifestyle interventions for diet/weight management to improve cognition among obese older adults is a public health priority.
However, no randomized controlled trials (RCTs) have examined the effect of the MedDiet with and without caloric restriction, to promote weight loss on cognitive functioning in obese older adults.
The investigators propose a three-arm RCT in which 180 obese (body mass index [BMI] ≥ 30 and < 50 kg/m²) older adults (55-80 years) will be randomized to: 1) an 8-month MedDiet Alone, without caloric restriction/weight loss (MedDiet-A); 2) an 8-month MedDiet lifestyle intervention with caloric restriction/weight loss (MedDiet-WL); or 3) an 8-month typical diet control (TDC) without caloric restriction/weight loss.
The investigators will test the following hypotheses: 1) participants randomized to MedDiet-A and MedDiet-WL will achieve greater improvements in cognition compared to participants randomized to TDC; 2) participants randomized to MedDiet-WL will exhibit greater improvements in cognition compared to participants randomized to MedDiet-A; 3) participants randomized to MedDiet-A and MedDiet-WL will show greater improvements in CVD/metabolic risk factors, systemic inflammation, OxStress, and body weight/composition compared to participants in TDC; 4) participants randomized to MedDiet-WL will exhibit greater improvements in CVD/metabolic risk factors, systemic inflammation, OxStress, and body weight/composition compared to MedDiet-A; 5) improvements in CVD/metabolic risk factors, body composition, systemic inflammation, and OxStress will mediate the relationship between MedDiet and improved cognition.
The investigators also will determine the extent to which changes in dietary habits, weight and cognitive functioning are maintained over a 6-month follow-up period.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
180
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
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Chicago, Illinois, Forenede Stater, 60608
- University of Illinois at Chicago
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The exclusion criteria ensure that participants can safely participate in the trial.
- 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) -
- currently on a weight-loss diet or actively involved in a formal weight loss program (e.g., Weight Watchers.)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: MedDiet-WL
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.
|
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. |
|
Eksperimentel: MedDiet-A
For the MedDiet-A group, dietary advice and corresponding exchange lists will be given within the context of promoting weight stability.
|
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. |
|
Andet: Typical Diet Control (TDC)
Typical Diet Control (TDC) will maintain current eating and activity patterns and weight over 14 months.
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessing change in Attention between time periods
Tidsramme: 14 months
|
Baseline, 8-month (first intervention), and 14-month assessments will include Digit Symbol test.
|
14 months
|
|
Assessing change in Executive Function between time periods
Tidsramme: 14 months
|
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
Tidsramme: 14 months
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marian Fitzgibbon, PhD, UIC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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. 2021 Apr 26:rs.3.rs-290482. doi: 10.21203/rs.3.rs-290482/v1. Preprint.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2016
Primær færdiggørelse (Faktiske)
1. januar 2021
Studieafslutning (Faktiske)
1. april 2021
Datoer for studieregistrering
Først indsendt
17. april 2017
Først indsendt, der opfyldte QC-kriterier
24. april 2017
Først opslået (Faktiske)
26. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016-0258
Plan for individuelle deltagerdata (IPD)
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