Clinical Trial: Energy Metabolism and Cognitive Aging
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Energy Metabolism and Cognitive Aging
Brief Summary: Participants 60 and older with and without Parkinson's disease who have mild cognitive decline will be randomized to either a standard higher carbohydrate diet or a carbohydrate-restricted ketogenic diet for 8 weeks. The main hypothesis is that nutritional ketosis will improve memory functioning. Pre and post-memory testing will be performed. Subjects will also provide blood samples and a subset of subjects with receive magnetic resonance brain imaging.
Detailed Summary:
Obesity and metabolic disturbance are recognized as important risks for disorders such as cardiovascular disease, stroke, and cancer. However, these conditions also contribute to age-related cognitive decline and dementia. In particular, insulin resistance and hyperinsulinemia promote neurocognitive dysfunction and neurodegenerative changes during the extended pre-clinical phase of Alzheimer's disease (AD). The prevalence of both metabolic disturbance and dementia are increasing dramatically, and in the absence of effective treatment, preventive approaches are essential to address the ominous public health concern represented by Alzheimer's disease and other forms of dementia. Dietary intervention is a promising and under-investigated preventive option. Regimens involving restricted carbohydrate consumption designed to induce ketone metabolism have been shown to improve metabolic parameters. In addition, ketone metabolism is associated with a host of benefits for neural function, among them enhanced mitochondrial energy production and reduction of neuropathological factors. Ketone feeding studies have demonstrated acute functional improvement in older adults with neurocognitive decline.
This research is designed to assess the efficacy of strict carbohydrate restriction in correcting hyperinsulinemia and improving neurocognitive function in older adults with early memory decline. Recently, we have shown that relatively brief intervention involving a low carbohydrate, ketogenic diet can improve memory in subjects with Mild Cognitive Impairment. We would like to extend these initial findings by adding new study arms involving older adult subjects with Parkinson's disease and Mild Cognitive Impairment. We also will increase the intervention period from six weeks to eight weeks.
Aim 1: To evaluate the effect of adaptation to ke
Sponsor: University of Cincinnati
Current Primary Outcome: improvement in memory testing [ Time Frame: 6 or 8 weeks ]
Original Primary Outcome: improvement in memory testing [ Time Frame: 6 weeks ]
Current Secondary Outcome: correlation between diet, metabolic factors, memory performance, and cerebral activation [ Time Frame: 6 or 8 weeks ]
Original Secondary Outcome: correlation between salivary cortisol levels and diet, blood sugar levels, inflammation and diet, increase in brain activity (measured by fMRI) [ Time Frame: 6 weeks ]
Information By: University of Cincinnati
Dates:
Date Received: October 21, 2008
Date Started: September 1, 2008
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017
