Lifestyle, Exercise and Diet: The LEAD Study (LEAD)

October 9, 2020 updated by: Carol Greenwood, Rotman Research Institute at Baycrest

Nutrition, Exercise and Lifestyle: Team 6 of the Canadian Consortium on Neurodegeneration in Aging (CCNA)

This study will explore the impact of an exercise and nutrition (EX+NUTR) , relative to exercise alone (EX) intervention, on brain structure and function as well as blood biomarkers in older adults with subjective cognitive decline (SCD) and vascular risk factors. The overall hypotheses are that a combined EX+NUTR, relative to EX, intervention will evoke more positive changes in brain structure (e.g. hippocampal volume), neural activity (e.g. task associated functional activations monitored through fMRI), and cognitive performance. These changes will be associated with an improved metabolic profile, reductions in inflammatory cytokines and oxidative burden, and greater intervention compliance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants will engage in group supervised exercise sessions once per week as well as engage in additional exercise sessions at home 4 days/week. The exercise program will be run out of two sites (Toronto Rehabilitation Institute (TRI) - Rumsey Centre in Toronto, and the Centre for Community, Clinical Applied Research Excellence (CCCARE) at the University of Waterloo). The supervised exercise sessions modeled after the standard TRI Cardiovascular Prevention and Rehabilitation program, including aerobic training, resistance training and education/counseling. The active group will receive strategy training to simultaneously improve their diet in conjunction with our newly developed Brain Health Food Guide (EX+BHFG); the placebo control group (EX+BHEd) will receive brain health education to control for time and social participation. [NOTE All participants must also be enrolled in the SCD cohort of the CCNA and undergo the CCNA's COMPASS-ND assessment at the beginning of the trial.] The study is 6 months in duration and requires participants to attend 2.5 hr weekly sessions (1 hr supervised exercise, 0.5 hr exercise/stress education and 1 hr nutrition or brain health education) and to exercise on their own an additional 3-4 times per week. Participants are assessed on measures of cognition, brain health (MRI), functional status at baseline, post intervention and 6 month follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M4G 2V6
        • Toronto Rehabilitation Institute Rumsey Centre
      • Toronto, Ontario, Canada, M6A 2E1
        • Rotman Research Institute
      • Waterloo, Ontario, Canada
        • Centre for Community, Clinical Applied Research Excellence (CCCARE) at the University of Waterloo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • meeting criteria for subjective cognitive impairment (1 through 5 below)

    1. Answer Yes to both following questions:

      1. Do you feel like your memory or thinking is becoming worse?
      2. Does this concern you?

    2. Have a delayed recall score on 1 paragraph of the Logical Memory test (Wechsler Memory Scale, maximum score 25) above the education-adjusted cut-offs:

      • ≥9 for 16+ years of education;
      • ≥5 for 8-15 years of education;
      • ≥3 for 0-7 years of education.
    3. Have a Montreal Cognitive Assessment (MoCA) total score of 20 and over (≥20/30).
    4. Have a delayed recall score on the CERAD word list of 5 and over (≥5).
    5. Have a global Clinical Dementia Rating score (CDR) equal to 0.5 or less (≤0.5).
  • ≥2 vascular risk factors (overweight (BMI>25), T2DM, hypercholesterolemia or hypertension),
  • Consuming a poor quality diet (at least median or below on number of servings of vegetable, fruit, fish and nuts based on Canadian consumption patterns in older adults)
  • Reasonably sedentary (less than 75min per week of moderate - vigorous intensity physical activity)
  • Be available for the whole intervention (6 months) and a 12- month follow-up visit
  • English speaking

Exclusion Criteria:

  • The presence of significant known chronic brain disease such as: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, malignant tumors, Parkinson's disease, and other rarer brain illnesses.
  • Ongoing alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
  • Subject does not have a study partner who can provide corroborative information.
  • Symptomatic stroke within the previous year.
  • Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure.
  • Major surgery within last 2 months.
  • History of intracranial surgery
  • Serious comorbid condition that, in the opinion of the study investigator, is likely to result in death within a year.
  • High performance athletes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise plus Nutrition
6 months of supervised group exercise plus education and strategy training to alter diet to be consistent with recommendations outlined in our brain health food guide (BHFG).
Behavioral: Exercise plus nutrition
On the same day as the exercise class, participants will also receive nutrition support. Participants will alter their overall diet to be consistent with recommendations outlined in our brain health food guide (BHFG) and receive diet counseling and strategy training to promote retention and enable this dietary change. For the first two months, diet group sessions will be held on a weekly basis. For the remaining four months, sessions will be divided between group sessions and individual meetings with study dietitians, on a predefined schedule. Participants will submit weekly logs outlining diet goals, plans, successes and obstacles to help direct identification of sequential goals.
Active Comparator: Exercise
Identical exercise to the experimental plus education and passive discussion about brain health and healthy lifestyle to control for experimental group nutrition sessions.
Behavioral: Exercise
Supervised group exercise will be performed once per week (60 minutes) and self-directed exercise (4 additional aerobic and 2-3 resistance training sessions per week) will be monitored by an exercise diary. The initial walking prescription will be set at ~1.6 km and an intensity equivalent to the anaerobic threshold and/or 60% VO2-peak. Progressions will be made every 2 weeks, increasing distance to a maximum of 6.4 km and then increasing to a max intensity of 80% of VO2-peak and/or max duration of 60 minutes. Heart rate and perceived exertion will be monitored. The program will last 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from baseline brain structure at 6 months and 12 months.
Time Frame: 6 months plus 6 month follow-up
Cortical and subcortical grey matter density using MRI three-dimensional T1 weighted structural scan (MPRAGE)
6 months plus 6 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline cerebral blood flow at 6 months and 12 months.
Time Frame: 6 months plus 6 month follow-up
Pseudo-continuous arterial spin labeling MRI (pcASL) to quantify cerebral blood flow
6 months plus 6 month follow-up
Changes from baseline cognition at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
pen and paper and computerized tasks, monitoring memory, executive function, and speed of processing. The results will be presented as a composite score of total neuro-psychological performance aggregating scores from the above cognitive domains.
6 months plus 6 month follow-up
Changes from baseline brain activity related to attention at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
BOLD functional MRI while participants performing an attention task
6 months plus 6 month follow-up
Changes from baseline resting state connectivity at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
BOLD functional MRI while participants at rest
6 months plus 6 month follow-up
Changes from baseline diet quality at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
Principle component analyses based on Canadian Diet History Questionnaire II (C-DHQII)
6 months plus 6 month follow-up
Changes from baseline adherence to diet recommendations at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
Principle component analyses based on the Eating Pattern Self-Assessment
6 months plus 6 month follow-up
Changes from baseline grip strength at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
Grip strength using a hand held dynamometer
6 months plus 6 month follow-up
Changes from baseline gait performance at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
Gait velocity, stride length/width, and associated variability assessed using a GAITRite pressure sensor mat.
6 months plus 6 month follow-up
Changes from baseline balance performance at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
Posturography assessment on balance platform
6 months plus 6 month follow-up
Changes from baseline maximal oxygen uptake at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
VO2max determined during cardiopulmonary assessment
6 months plus 6 month follow-up
Changes from baseline blood moderators at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
e.g. BDNF, pro-BDNF, ApoE,
6 months plus 6 month follow-up
Changes from baseline HbA1C at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
HbA1C
6 months plus 6 month follow-up
Changes from baseline fasting glucose at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
fasting glucose
6 months plus 6 month follow-up
Changes from baseline insulin levels at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
insulin
6 months plus 6 month follow-up
Changes from baseline lipid levels at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
lipid profile
6 months plus 6 month follow-up
Changes from baseline homocysteine levels at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
homocysteine
6 months plus 6 month follow-up
Changes from baseline C reactive protein levels at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
CRP
6 months plus 6 month follow-up
Changes from baseline TNF-alpha levels at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
TNF-alpha
6 months plus 6 month follow-up
Changes from baseline IL6 levels at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
IL6
6 months plus 6 month follow-up
Changes from baseline vitamin K levels at 6 months and 12 months
Time Frame: 6 months plus 6 month follow-up
Vitamin K
6 months plus 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rotman Research Institute at Baycrest

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sunnybrook Health Sciences Centre
University of Waterloo
Toronto Rehabilitation Institute
The Centre for Memory and Aging

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carol E Greenwood, PhD, Rotman Research Institute Baycrest Health Sciences
  • Principal Investigator: Nicole D Anderson, PhD, Rotman Research Institute Baycrest Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCNA-NELT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

data will be uploaded to shared CCNA database - LORIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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