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.

Açaí (Euterpe oleracea Mart.) beverage consumption improves biomarkers for inflammation but not glucose- or lipid-metabolism in individuals with metabolic syndrome in a randomized, double-blinded, placebo-controlled clinical trial

2018 ◽  
Vol 9 (6) ◽  
pp. 3097-3103 ◽  
Author(s):  
Hyemee Kim ◽  
Sunday Y. Simbo ◽  
Chuo Fang ◽  
Lilly McAlister ◽  
Andrea Roque ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Metabolic Syndrome ◽  
Clinical Trial ◽  
Lipid Metabolism ◽  
Controlled Clinical Trial ◽  
Euterpe Oleracea ◽  
Beverage Consumption ◽  
Double Blinded ◽  
And Oxidative Stress ◽  
Euterpe Oleracea Mart

Açaí beverage consumption may reduce biomarkers for inflammation and oxidative stress in metabolic syndrome.

Liraglutide as an Additional Treatment to Insulin in Patients with Type 1 Diabetes Mellitus—A 52-Week Randomized Double-Blinded Placebo-Controlled Clinical Trial

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 3-LB ◽  
Author(s):  
PARESH DANDONA ◽  
HUSAM GHANIM ◽  
NITESH D. KUHADIYA ◽  
TANVI SHAH ◽  
JEANNE M. HEJNA ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trial ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Additional Treatment ◽  
Controlled Clinical Trial ◽  
Double Blinded

scholarly journals Administration of Apple Polyphenol Supplements for Skin Conditions in Healthy Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1071
Author(s):  
Toshihiko Shoji ◽  
Saeko Masumoto ◽  
Nina Moriichi ◽  
Yasuyuki Ohtake ◽  
Tomomasa Kanda
Keyword(s):  
Clinical Trial ◽  
Uv Irradiation ◽  
Skin Pigmentation ◽  
Controlled Clinical Trial ◽  
Continuous Administration ◽  
Double Blind ◽  
Healthy Women ◽  
Dependent Relationship ◽  
Skin Conditions ◽  
Double Blinded

This clinical study was performed to evaluate the effects of continuous apple polyphenol (AP) administration on facial skin conditions and pigmentation induced by ultraviolet (UV) irradiation in healthy women participants. Participants (n = 65, age 20–39 years) were randomized to receive tablets containing AP (300 or 600 mg/day) or placebo in a double-blinded, placebo-controlled clinical trial. Continuous administration of AP for 12 weeks significantly prevented UV irradiation induced skin pigmentation (erythema value, melanin value, L value), although a dose-dependent relationship was not clearly observed. In contrast, no significant differences were detected between the groups with regard to water content and trans-epidermal water loss. Our study demonstrated that APs and their major active compounds, procyanidins, have several health benefits. Here, we report that continuous administration of AP for 12 weeks alleviated UV irradiation induced skin pigmentation, when compared with placebo, in healthy women.

scholarly journals No Beneficial Effects of Resveratrol on the Metabolic Syndrome: A Randomized Placebo-Controlled Clinical Trial

2017 ◽  
Vol 102 (5) ◽  
pp. 1642-1651 ◽  
Author(s):  
Thomas Nordstrøm Kjær ◽  
Marie Juul Ornstrup ◽  
Morten Møller Poulsen ◽  
Hans Stødkilde-Jørgensen ◽  
Niels Jessen ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Beneficial Effects ◽  
The Metabolic Syndrome
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