N/A
N=98
Dietary Ketosis: Fatty Acids Activate AMPK Energy Circuits Modulating Global Methylation
Mild Cognitive Impairment · Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03319173 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: MoCA (Montreal Cognitive Assessment) — 28.38; 20.22 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dietary intervention (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Bristlecone Health, Inc.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MoCA (Montreal Cognitive Assessment) |
28.38; 20.22 | <0.0001 sig |
| SECONDARY NMR Lipoprofile Particle Size - Small LDL-P |
276.24; 588.08 | <0.0001 sig |
| SECONDARY NMR Lipoprofile Particle Size - LP-IR Score (Lipoprotein Insulin Resistance) Ideal Range: <45 |
32.13; 50.66 | <0.0001 sig |
| SECONDARY Fasting Triglycerides |
87.23; 131.73 | <0.0001 sig |
| SECONDARY Triglyceride/HDL Ratio |
1.67; 2.69 | <0.0001 sig |
| SECONDARY Fasting Insulin |
7.32; 11.25 | <0.0001 sig |
| SECONDARY Fasting Glucose |
85.9; 109.61 | <0.0001 sig |
| SECONDARY HOMA-IR |
1.55; 3.05 | <0.0001 sig |
| SECONDARY HgA1c |
5.19; 5.82 | <0.0001 sig |
| SECONDARY Weight |
200.23; 210.60 | <0.0001 sig |
| SECONDARY Body Fat Mass (BFM) |
67.95; 79.35 | <0.0001 sig |
| SECONDARY VLDL |
17.45; 26.35 | <0.0001 sig |
| SECONDARY SAM/SAH Ratio (S-adenosylmethionine/S-adenosylhomocysteine) |
4.938; 4.491 | <0.0001 sig |
| SECONDARY SAM (S-adenosylmethionine) |
89.784; 88.177 | <0.0001 sig |
| SECONDARY SAH (S-adenosylhomocysteine) |
18.257; 19.566 | <0.0001 sig |
| SECONDARY Adenosine |
23.363; 21.475 | <0.0001 sig |
Summary
The study explores whether selective memory complaints (SMC), mild cognitive impairment (MCI) and the comorbidity of Metabolic Syndrome symptomatic of peripheral and cerebral hypo-metabolism with corresponding epigenetic shifts in global DNA (deoxyribonucleic acid) methylation (away from nutrient availability and toward biosynthesis) are initiated by chronic metabolic inflexibility, over-activation of the mTOR (mammalian target of rapamycin) pathway, and the deregulation of neural oxidative phosphorylation.
Eligibility Criteria
Inclusion Criteria
- Male or Female (age 35-80)
- Previously diagnosed with MetS and/or T2DM as measured by possessing at least two of the following physiological measures: type 2 diabetes, BMI > 30, HgA1c > 5.7%, waist/height ratio > .6, fasting glucose > 125 mg/dL
- Subjective Memory Complaints (SCM) - Subjects score > 3 'yes' answers on the Subjective Memory Complaints Questionnaire
- Previously diagnosed with Mild Cognitive Impairment (MCI)
Exclusion Criteria
- Previously diagnosed with Alzheimer's disease (AD), dementia or Parkinson's disease
Data sourced from ClinicalTrials.gov (NCT03319173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.