How to design nutritional intervention trials to slow cognitive decline in apparently healthy populations and apply for efficacy claims: A statement from the international academy on nutrition and aging task force

Abstract

Interventions are crucial as they offer simple and inexpensive public health solutions that will be useful over the long term use. A Task Force on designing trials of nutritional interventions to slow cognitive decline in older adults was held in Toulouse in September 2012. The aim of the Task Force was to bring together leading experts from academia, the food industry and regulatory agencies to determine the best trial designs that would enable us to reach our goal of maintaining or improving cognitive function in apparently healthy aging people. An associated challenge for this Task Force was to determine the type of trials required by the Public Food Agencies for assessing the impact of nutritional compounds in comparison to well established requirements for drug trials. Although the required quality of the study design, rationale and statistical analysis remains the same, the studies designed to show reduction of cognitive decline require a long duration and the objectives of this task force was to determine best design for these trials. Two specific needs were identified to support trials of nutritional interventions: 1- Risk- reduction strategies are needed to tackle the growing burden of cognitive decline that may lead to dementia, 2- Innovative study designs are needed to improve the quality of these studies.

Vitamin B12, B6, or Folate and Cognitive Function in Community-Dwelling Older Adults: A Systematic Review and Meta-Analysis

“…Cognitive decline, as observed in mild cognitive impairment (MCI), Alzheimer's disease (AD), and other dementias, has been one of the most common and costly chronic conditions contributing to decreases in the quality of life [1][2][3][4][5][6]. According to the National Center of Health Statistics (NCHS) and World Alzheimer Report 2015, the number of dementia patients worldwide will triple to 135.5 million by 2050 [7].…”

N-of-1 Clinical Trials in Nutritional Interventions Directed at Improving Cognitive Function

“…On the other hand, MCI is considered a prodromal stage of AD although it does not strictly imply progression to clinically defined dementia (48). Use of the MCI category has been a matter of debate (9, 49) since it is irregularly defined and some subtypes are more likely to progress to dementia than others (50).…”

“…Indeed, optimal nutrition is a key component for healthy aging. Nutritional preventive interventions present unique advantages in terms of costs, safety, and sustainability for long-term use (9, 10).…”

Geriatrics in the 21st century

“…A Mediterranean diet with extra virgin olive oil delays the loss of cognition and may prevent Alzheimer's disease (130)(131)(132). A number of other nutritional approaches have been tried with limited success (133)(134)(135)(136). Dementia has decreased in the USA most probably because of increased treatment of cardiovascular risk factors (137).…”