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Study: Diet and Exercise Study to Improve Brain Blood Flow: Blood Flow Improvement Trial (BFIT)

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ClinicalTrials.gov Identifier: NCT03117829
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

Project Summary Metabolic syndrome (MetS) is associated with the development of diabetes and cardiovascular disease; however it is also linked with cognitive decline and dementia. The study investigators have shown that MetS is associated with lower cerebral blood flow (CBF) and memory function in late middle-aged adults at increased risk for developing Alzheimer's disease (AD). Insulin resistance (IR) is at the core of MetS, and a hallmark feature of IR is higher fasting blood glucose (FBG) as well as post prandial hyperglycemia.

While the study investigators and others have demonstrated links between IR and CBF as well as cognition from an observational perspective, no studies have investigated CBF and cognition after an intervention involving exercise and a carbohydrate restricted diet (CRD) designed to improve or normalize IR and glucose homeostasis. The study investigators propose to determine the effect of improving or normalizing glucose homeostasis on CBF and cognition, through diet and exercise, in individuals with IR and at risk for the development of AD.

While exercise and a CRD have been shown to improve IR and glycemic control, we have only limited knowledge of the mechanisms behind these improvements. Nutritional metabolomics, the global measurement and interpretation of metabolic profiles, assesses the interaction of diet with the endogenous gene-protein cascade and the gut microbiome. Additionally, exercise has been shown to have an impact on the human metabolome. Finally, numerous metabolites have been specifically linked to IR and impaired fasting glucose (IFG). The study investigators propose to use metabolomics to measure changes in metabolites as individuals normalize or improve IR and glucose homeostasis.

Should this exploratory study reveal increased brain blood flow and improved memory in response to diet and exercise, then early treatment of these individuals at risk might offer new avenues for disease-course modification. Strategies towards early and effective risk factor management could be of value in reducing the risk of metabolic as well as cognitive decline. In addition, should this study reveal changes in metabolic abnormalities consistent with early indications of diabetes, metabolomics could be an effective approach to complement disease risk analysis in our goal toward precision care.


Condition or disease Intervention/treatment Phase
PreDiabetes Behavioral: Diet and Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Diet and Exercise Trial to Improve Insulin Resistance, Increase Cerebral Blood Flow, Alter Metabolomic Biomarkers, and Decrease Alzheimer's Disease Risk
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : June 17, 2019


Arm Intervention/treatment
Experimental: Improve Brain Blood Flow
12 week diet and exercise program to improve brain blood flow
Behavioral: Diet and Exercise
Diet and Exercise Study to Improve Brain Blood Flow




Primary Outcome Measures :
  1. Change in brain blood flow from baseline to 12 weeks [ Time Frame: baseline and 12 weeks ]
    Change in brain blood flow from baseline to 12 weeks


Secondary Outcome Measures :
  1. Change in brain blood flow from 12 weeks to 6 month post intervention [ Time Frame: 12 weeks and 6 months post intervention ]
    Change in brain blood flow from 12 weeks to 6 month post intervention



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants from the Wisconsin Alzheimer's Disease Research Center (ADRC) -

Exclusion Criteria:

  • . Exclusion criteria are: active lifestyle (exercise >1 hour/wk); body mass index > 40; MRI contraindications; history of neurological disease, prior neurosurgery; diagnosed and/or treated type 1 or 2 diabetes; pregnancy; acute or subacute active cardiac disease (ongoing chest pain or myocardial infarction < 3 months); significant orthopedic or musculoskeletal condition that limits weight bearing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117829


Locations
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United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Randall J Gretebeck, PhD University of Wisconsin, Madison

Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03117829     History of Changes
Other Study ID Numbers: 2016-1202
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases