Lifestyle, Exercise and Diet: The LEAD Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03056508
• Date of registration: 09/02/2017
• Prospective Registration: Yes
• Primary sponsor: Rotman Research Institute at Baycrest
• Public title: Lifestyle, Exercise and Diet: The LEAD Study LEAD
• Scientific title: Nutrition, Exercise and Lifestyle: Team 6 of the Canadian Consortium on Neurodegeneration in Aging (CCNA)
• Date of first enrolment: July 1, 2018
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03056508
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Carol E Greenwood, PhD
• Affiliation: Rotman Research Institute Baycrest Health Sciences

• Name: Nicole D Anderson, PhD
• Affiliation: Rotman Research Institute Baycrest Health Sciences

Key inclusion & exclusion criteria

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



Age minimum: 60 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Age-Related Cognitive Decline

Subjective Cognitive Decline

Intervention(s)

Behavioral: Exercise plus nutrition

Behavioral: Exercise

Primary Outcome(s)

Changes from baseline brain structure at 6 months and 12 months. [Time Frame: 6 months plus 6 month follow-up]

Secondary Outcome(s)

Changes from baseline C reactive protein levels at 6 months and 12 months [Time Frame: 6 months plus 6 month follow-up]

Changes from baseline cerebral blood flow at 6 months and 12 months. [Time Frame: 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]

Changes from baseline maximal oxygen uptake at 6 months and 12 months [Time Frame: 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]

Changes from baseline lipid levels at 6 months and 12 months [Time Frame: 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]

Changes from baseline vitamin K levels at 6 months and 12 months [Time Frame: 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]

Changes from baseline gait performance at 6 months and 12 months [Time Frame: 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]

Changes from baseline grip strength at 6 months and 12 months [Time Frame: 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]

Changes from baseline insulin levels at 6 months and 12 months [Time Frame: 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]

Changes from baseline diet quality at 6 months and 12 months [Time Frame: 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]

Changes from baseline brain activity related to attention at 6 months and 12 months [Time Frame: 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]

Changes from baseline resting state connectivity at 6 months and 12 months [Time Frame: 6 months plus 6 month follow-up]

Secondary ID(s)

CCNA-NELT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sunnybrook Health Sciences Centre

Toronto Rehabilitation Institute

University of Waterloo

The Centre for Memory and Aging