Study protocol: A randomised, double blinded, placebo-controlled clinical trial testing the effects of a vitamin D-enriched mushroom supplement on cognitive performance and mood in healthy elderly adults

2016 ◽  
Vol 05 (01) ◽  
Author(s):  
Ian Zajac ◽  
Paul Cavuoto ◽  
Vanessa Danthiir ◽  
Gary A Wittert ◽  
Debra Krause ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Cognitive Performance ◽  
Study Protocol ◽  
Controlled Clinical Trial ◽  
Elderly Adults ◽  
Healthy Elderly ◽  
Trial Testing ◽  
Double Blinded

Ketone Ester Effects on Biomarkers of Brain Metabolism and Cognitive Performance in Cognitively Intact Adults ≥ 55 Years Old. A Study Protocol for a Double-Blinded Randomized Controlled Clinical Trial

2022 ◽  
pp. 1-12
Author(s):  
K.I. Avgerinos ◽  
R.J. Mullins ◽  
J.M. Egan ◽  
D. Kapogiannis
Keyword(s):  
Metabolic Syndrome ◽  
Clinical Trial ◽  
Cognitive Performance ◽  
Animal Studies ◽  
Brain Metabolism ◽  
Ketone Bodies ◽  
Controlled Clinical Trial ◽  
Resonance Spectroscopy ◽  
Double Blinded ◽  
Cognitively Intact

BACKGROUND: Ketone bodies have been proposed as an “energy rescue” for the Alzheimer’s disease (AD) brain, which underutilizes glucose. Prior research has shown that oral ketone monoester (KME) safely induces robust ketosis in humans and has demonstrated cognitive-enhancing and pathology-reducing properties in animal models of AD. However, human evidence that KME may enhance brain ketone metabolism, improve cognitive performance and engage AD pathogenic cascades is scarce. Objectives: To investigate the effects of ketone monoester (KME) on brain metabolism, cognitive performance and AD pathogenic cascades in cognitively normal older adults with metabolic syndrome and therefore at higher risk for AD. Design: Double-blinded randomized placebo-controlled clinical trial. Setting: Clinical Unit of the National Institute on Aging, Baltimore, US. Participants: Fifty cognitively intact adults ≥ 55 years old, with metabolic syndrome. Intervention: Drinks containing 25 g of KME or isocaloric placebo consumed three times daily for 28 days. Outcomes: Primary: concentration of beta-hydroxybutyrate (BHB) in precuneus measured with Magnetic Resonance Spectroscopy (MRS). Exploratory: plasma and urine BHB, multiple brain and muscle metabolites detected with MRS, cognition assessed with the PACC and NIH toolbox, biomarkers of AD and metabolic mediators in plasma extracellular vesicles, and stool microbiome. Discussion: This is the first study to investigate the AD-biomarker and cognitive effects of KME in humans. Ketone monoester is safe, tolerable, induces robust ketosis, and animal studies indicate that it can modify AD pathology. By conducting a study of KME in a population at risk for AD, we hope to bridge the existing gap between pre-clinical evidence and the potential for brain-metabolic, pro-cognitive, and anti-Alzheimer’s effects in humans.

scholarly journals Vitamin D supplementation to prevent depression and poor physical function in older adults: Study protocol of the D-Vitaal study, a randomized placebo-controlled clinical trial

2015 ◽  
Vol 15 (1) ◽  
Author(s):  
Elisa J. de Koning ◽  
Natasja M. van Schoor ◽  
Brenda W.J.H. Penninx ◽  
Petra J.M. Elders ◽  
Annemieke C. Heijboer ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
Vitamin D ◽  
Physical Function ◽  
Study Protocol ◽  
Vitamin D Supplementation ◽  
Controlled Clinical Trial

The Role of Vitamin D Supplementation in the Treatment of Primary Hypertension: A Double-Blinded Randomized Placebo-Controlled Clinical Trial

2020 ◽  
Vol 22 (7) ◽  
Author(s):  
Samira Faraji ◽  
Rasoul Zarrin ◽  
Asma Zamanian ◽  
Reza Hajizadeh ◽  
Parvin Ayremlou ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Vitamin D ◽  
Lipid Profile ◽  
Vitamin D Deficiency ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Controlled Clinical Trial ◽  
Hypertensive Patients ◽  
Double Blinded

Background: Hypertension is one of the most serious global concerns since it has affected over 1.2 billion people. Objectives: The present study aimed to determine the effect of vitamin D supplementation on blood pressure, fasting blood sugar, and lipid profile in hypertensive patients with vitamin D deficiency. Methods: In this double-blinded randomized placebo-controlled clinical trial study, 116 hypertensive patients (intervention and placebo groups, 58 each) with vitamin D deficiency (< 30 ng/mL with ECL) for 14 weeks, started from the beginning of autumn 2019 in Seyed-al-Shohada Educational Hospital in Urmia City. Fifty-five patients (49%) were male with the mean vitamin D 15.89 ± 5.09 ng/mL and 57 females with 17.29 ± 6.31 ng/mL. In a stratified blocked randomization scheme, the patients were randomly allocated into similar sized intervention and control groups based on body mass index (BMI), then the randomization with four block size was performed in each of strata by random allocation software. The intervention group received six doses of 50,000 IU vitamin D supplements for 6 weeks, then two supplements for two following months (one capsule per month). Blood pressure (24/h blood pressure measured by an ambulatory blood pressure monitoring device), vitamin D, FBS, and lipid profile (HDL, LDL, CL, and TG) were all measured at baseline and end of the study. Physical activity (measured by short IPAQ questionnaire), sun exposure using a questionnaire, dietary intake of vitamin D using three 24-hour recalls during the intervention, and anthropometric indices were measured at baseline, middle, and end of the study. Fifty-six patients in each group completed the study. The study was approved by the Ethics Committee of the Urmia University of Medical Sciences (ethics code: IR.UMSU.REC.1398.192). Results: The office blood pressure, 24-h systolic blood pressure (SBP) and diastolic blood pressure (DBP), nighttime SBP and DBP were significantly reduced in the intervention group compared to the control group, whereas the reduction of daytime SBP and DBP was not statistically significant. Vitamin D supplementation significantly decreased serum triglyceride, cholesterol, and LDL levels. Conclusions: Vitamin D supplementation had positive effects on blood pressure, triglyceride, cholesterol, and LDL levels in patients with low serum vitamin D.

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