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 STUDY 1.

TITLE: Identification of reference ranges for the NAD metabolome in whole blood from various human populations

Recruiting from: 06 August 2023                      

You are invited to take part in a study to determine the normal range of a molecule called NAD+, and its related derivatives, in blood.

  1. What is the purpose of the study?

Nicotinamide adenine dinucleotide (NAD+) is a molecule with many important functions. Without adequate NAD+, cells in the body find it difficult to carry out a number of essential tasks. These include, producing energy for the body to perform well, repairing cells with damaged DNA and coordinating a healthy immune response. Recent studies have observed that NAD+ levels decrease as we get older in line with the higher risk of disorders such as muscle weakness, cancer and some dementias. Though there have been a range of therapies developed with the aim of increasing NAD+ levels, surprisingly it is not yet clear what level of NAD+ is too low, indicating risk for disease, and conversely what the optimum level of NAD+ should be.
Therefore the purpose of this study is to determine:

  • What is the normal range of NAD+ values in a healthy population across the adult age range.
  • What factors affect a person’s NAD+ levels; is it only age or do other variables such as pregnancy, gender, clinical condition (e.g. diabetes etc.) or other lifestyle factors (e.g. diet, physical activity etc.) play a significant role?

Who can participate?

We are looking for individuals from the general population who:

  • are aged 18 years or older,
  • do not have a current cancer diagnosis,
  • if previously diagnosed with cancer (except basal or squamous cell skin cancer), have been in remission for at least 5 years,
  • have not been receiving treatment for cancer within the last 2 years,
  • are not addicted to tobacco or alcohol,
  • have not had a known infection within the last 2 weeks,
  • do not have a known autoimmune disease,
  • have not received a vaccination or vaccine booster for at least 4 weeks,
  • if pregnant, are not considered high risk.

If you would like to participate in this study or want to know more please contact:
 
Dr Ross Grant (Chief Investigator)
     ph: (02) 94809602
email: rossg@sah.org.au
_________________________________________________________________________________________________________________________________________________

STUDY 2


Title: Brain enhancement study (BES): Can optimising biochemical parameters (targets) via participation in a multi-modal lifestyle-based intervention improve cognition in amnestic MCI.

Recruiting from 01 Feb 2024 (however expressions of interest invited before this date)

Invitation

You are invited to take part in a study that is investigating the effectiveness of a personalised multi-modal intervention to improve cognition, behavioural function and mood, in individuals who have mild but measurable declines in memory (i.e. who have mild cognitive impairment; MCI).

What is the purpose of the study?

Mild cognitive impairment (MCI) is the stage between the expected cognitive decline of normal aging and the severe reductions observed in dementia, including Alzheimer’s Disease (AD). In one year, between 10 to 15% of those with MCI develop AD. Over six years this figure increases to approximately 80%. Of concern, despite decades of research, no drug has been found which effectively prevents the progression of the disease. Fortunately, emerging evidence indicates that multi-modal, lifestyle based interventions, may at least stabilise cognition. Therefore the purpose of this study is to evaluate the effectiveness of a 6 month, personalised, lifestyle based, multi-modal intervention to stabilise or improve cognition in those with MCI.

What does this study involve for those eligible to take part?

If eligible to take part in this study, both the participant and their study companion will be randomly allocated, as a pair, to one of two groups; the Intervention or the Control. For every five pairs entering the study, three will randomly allocated to the Intervention and two will be randomly allocated to the Control. Please note, after participation in the Control Group individuals will have the opportunity to take part in the Intervention if they choose.

CONTROL GROUP (Complete assessments only). As part of the Control Group, both the participant and their companion will be asked to complete a number of assessments. This will occur at two time points, over a period of 24 weeks (i.e. 6 months). The types of assessments participants and companions of the Control Group will be asked to complete are described in Point 6 (pg. 7) and Point 7 (pg. 10) respectively. Assessment timing is described in Point 8 (see consent form). At the end of the study, a copy of assessment results will be provided.  At this time, participants and companions of the Control Group will have the opportunity to immediately commence the Intervention, as detailed below, if they choose.

INTERVENTION GROUP (Intervention + Assessments)

Pairs allocate to the Intervention Group will be asked to complete the Intervention as detailed below.The Intervention runs for 24 weeks (i.e. 6 months) and is divided into three phases.

Phase 1: Preparation (14 days)          
The purpose of Phase 1 is to help the participant (and companion), gradually adjust to the changes in lifestyle commencing in Phase 2. To achieve this, during Phase 1 we will ask the participant to a) reduce intake of meat, coffee and alcohol, b) increase intake of fruit and vegetables and c) cease consumption of non-prescribed supplements. If not already partaking in regular physical activity, the participant will also be asked to commence light levels of activity as appropriate for their health (e.g. walking).           It is highly desirable and helpful if the companion chooses to make the same lifestyle adjustments at this time.  
 
Phase 2: Intensive (5 ½ days) 
The purpose of Phase 2, is to help the participant adopt brain healthy behaviours. We will ask and assist the participant, with the support of their companion, to reach the specific goals set for the program. Some of these, including Nutrition and Cognitive training, are anticipated to be achieved almost immediately. Other, including Physical activity and Optimised biorhythms may take longer.

An evidence based, dietician approved, brain healthy, plant-based diet will be modelled through the provision of ALL meals to both the participant and companion during this Phase. Participants will also be asked to commence the daily consumption of a nutrient fortified edible food supplement. This includes various nutrients, scientifically validated to promote brain health.

Phase 3: Home Implementation        

Part A (4 weeks)

During Home Implementation Part A, a Study Coach will visit the participant’s home 1-3 times per week. The number of weekly visits will be decided by the participant and companion.The purpose of these visits is to help implement within the home, the changes in behaviour initiated during the Intensive. 

During this phase participants will also start their personalised exercise plan. This plan will help participants safely progress to the level of physical activity listed in Table 2. It is highly desirable for companions to join participants in their exercise routine if safe to do so (as stipulated by their doctor).  

Participants and their companion will also be asked to join fellow study members in one group exercise session per week. This will be run by the Study Exercise Physiologist or Personal Trainer.

Part B (19 weeks)

During Home Implementation Part (B), in person visits by the Study Coach will be replaced by weekly phones calls and/or online meetings.
Participants, and their companions, will be asked to continue their personalised exercise plan and weekly group exercise session. The exercise plan will be updated at least twice during this period.

Throughout Phase 3, the Study Coach and Chief Investigators will have weekly meetings to discuss the progress of participants and any issues/concerns/complex questions raised by either the participant or companion. This will occur in consultation with the Study Doctor or Exercise Physiologist/Personal Trainer as appropriate

If you would like to know more, please contact us using the details below:

Dr Jade Berg
Email: jade.berg@sah.org.au
Phone: 0410 434 707