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

NCT03117829 | Completed

• 4 other identifiers: 2016-1202A534255SMPH/MEDICINE/GER-AD DEV1R21AG053738-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Change in brain blood flow from baseline to 12 weeks

  Change in brain blood flow from baseline to 12 weeks

  baseline and 12 weeks

Secondary Outcomes (1)

• Change in brain blood flow from 12 weeks to 6 month post intervention

  12 weeks and 6 months post intervention

Study Arms (1)

Improve Brain Blood Flow

EXPERIMENTAL

12 week diet and exercise program to improve brain blood flow

Behavioral: Diet and Exercise

Interventions

Diet and Exercise BEHAVIORAL

Diet and Exercise Study to Improve Brain Blood Flow

Improve Brain Blood Flow

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Randall J Gretebeck, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 18, 2017
• Study Start: March 15, 2017
• Primary Completion: December 18, 2018
• Study Completion: June 17, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)