Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2019-04-01
2019-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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HVMN ketone drink
HVMN ketone drink will be given in a total volume of 100 ml.
HVMN Ketone
Water-based, flavoured sport beverage
Placebo
Placebo will be given in a total volume of 100 ml.
Placebo
Water, stevia, malic acid, and thickening agent
Interventions
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HVMN Ketone
Water-based, flavoured sport beverage
Placebo
Water, stevia, malic acid, and thickening agent
Eligibility Criteria
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Inclusion Criteria
* Individuals diagnosed with prediabetes; defined based on the American Diabetes Association guidelines
* History of at least one episode of acute pancreatitis
* Written informed consent
Exclusion Criteria
* History of cancer or chronic pancreatitis
* History of bariatric or gastrointestinal surgery
* Pregnant or breastfeeding women
* Individuals involved in intensive endurance training or competitive athletics
18 Years
ALL
No
Sponsors
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University of Auckland, New Zealand
OTHER
Responsible Party
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Max Petrov
Associate Professor
Locations
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University of Auckland; Auckland City Hospital
Auckland, , New Zealand
Countries
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References
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Charles S, Liu Y, Bharmal SH, Kimita W, Petrov MS. Effect of Acute Nutritional Ketosis on Circulating Levels of Growth Differentiation Factor 15: Findings from a Cross-Over Randomised Controlled Trial. Biomolecules. 2024 Jun 6;14(6):665. doi: 10.3390/biom14060665.
Charles S, Liu Y, Kimita W, Ko J, Bharmal SH, Petrov MS. Effect of D-beta-hydroxybutyrate-(R)-1,3 butanediol on plasma levels of asprosin and leptin: results from a randomised controlled trial. Food Funct. 2023 Jan 23;14(2):759-768. doi: 10.1039/d2fo02405e.
Liu Y, Bharmal SH, Kimita W, Petrov MS. Effect of d-beta-Hydroxybutyrate-(R)-1,3 Butanediol on Appetite Regulation in People with Prediabetes. Mol Nutr Food Res. 2023 Feb;67(4):e2200615. doi: 10.1002/mnfr.202200615. Epub 2023 Jan 26.
Liu Y, Bharmal SH, Kimita W, Petrov MS. Effect of acute ketosis on lipid profile in prediabetes: findings from a cross-over randomized controlled trial. Cardiovasc Diabetol. 2022 Jul 23;21(1):138. doi: 10.1186/s12933-022-01571-z.
Bharmal SH, Alarcon Ramos GC, Ko J, Petrov MS. Abdominal fat distribution modulates the metabolic effects of exogenous ketones in individuals with new-onset prediabetes after acute pancreatitis: Results from a randomized placebo-controlled trial. Clin Nutr ESPEN. 2021 Jun;43:117-129. doi: 10.1016/j.clnesp.2021.03.013. Epub 2021 Mar 21.
Bharmal SH, Cho J, Alarcon Ramos GC, Ko J, Cameron-Smith D, Petrov MS. Acute Nutritional Ketosis and Its Implications for Plasma Glucose and Glucoregulatory Peptides in Adults with Prediabetes: A Crossover Placebo-Controlled Randomized Trial. J Nutr. 2021 Apr 8;151(4):921-929. doi: 10.1093/jn/nxaa417.
Other Identifiers
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18/NTB/161
Identifier Type: -
Identifier Source: org_study_id
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