The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.
New-onset prediabetes is the most significant risk factor for diabetes. Clinical studies in healthy human volunteers have demonstrated that ketone esters lower blood glucose levels in both fasting and fed state. Participants will visit the COSMOS clinic on two occasions and will be randomly allocated to receive either the HVMN ketone drink or placebo, in a cross-over design. Blood samples will be collected sequentially every 30 minutes for up to 150 minutes. Blood samples will be assayed for glucose and other markers of glucose metabolism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
18
Water-based, flavoured sport beverage
Water, stevia, malic acid, and thickening agent
University of Auckland; Auckland City Hospital
Auckland, New Zealand
Rate of change in plasma glucose concentration
Changes in plasma glucose concentration before and after administration of the intervention/placebo
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma insulin and C-peptide concentrations
Changes in plasma insulin and C-peptide concentrations before and after administration of the intervention/placebo
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of gut and pancreatic hormones
Changes in plasma concentrations of ghrelin, incretins, cholecystokinin, gastrin-releasing peptide, peptide YY, oxyntomodulin, motilin, glucagon, amylin, pancreatic polypeptide, and vasoactive intestinal peptide before and after administration of the intervention/placebo
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in lipid profile and digestive enzymes
Changes in plasma concentration of triglycerides, glycerol, cholesterol, lipases before and after administration of the intervention/placebo
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of pro-inflammatory cytokines
Changes in plasma concentration of interleukin-1β, interleukin-6, leptin, tumor necrosis factor α, and monocyte chemoattractant protein-1 and other cytokines before and after administration of the intervention/placebo
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of markers of iron metabolism
Changes in plasma concentration of ferritin, hepcidin, transferrin receptor before and after administration of the intervention/placebo
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Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Correlation with body fat phenotypes
Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived visceral fat volume in the intervention/placebo
Time frame: 150 minutes
Correlation with body fat phenotypes
Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived subcutaneous fat volume in the intervention/placebo
Time frame: 150 minutes
Correlation with body fat phenotypes
Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived liver fat per centage in the intervention/placebo
Time frame: 150 minutes
Correlation with physical activity
Differences in the association between rate of change in plasma glucose concentration and metabolic equivalents score in the intervention/placebo
Time frame: 150 minutes