PreDiabetesCETUSNCT03889210
β-hydroxybutyrate, Glucose Metabolism and Prediabetes
A study testing HVMN Ketone in people with PreDiabetes, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- HVMN Ketone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Apr 2019to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals over 18 years
- Individuals diagnosed with prediabetes; defined based on the American Diabetes Association guidelines
- History of at least one episode of acute pancreatitis
- Written informed consent
Who cannot join
- Individuals who are on a ketogenic diet or consuming nutritional ketone supplements
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-over, Placebo-controlled, Randomized Trial of β-hydroxybutyrate in Prediabetes
The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.
Read the detailed description
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.
- Conditions
- PreDiabetes
- Being tested
- HVMN Ketone, Placebo
- Keywords
- Ketones, Prediabetes
- Medical subject headings
- Prediabetic State, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVMN KetoneOther
Water-based, flavoured sport beverage
PlaceboOther
Water, stevia, malic acid, and thickening agent
| Study group | Role | What they receive |
|---|---|---|
| HVMN ketone drink | Active comparator | HVMN ketone drink will be given in a total volume of 100 ml. Receives: Other: HVMN Ketone |
| Placebo | Placebo comparator | Placebo will be given in a total volume of 100 ml. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in plasma glucose concentration
Changes in plasma glucose concentration before and after administration of the intervention/placebo
Measured: Baseline, 30, 60, 90, 120, and 150 minutes
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019
- Primary completion16 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Petrov, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889210
- Sponsor's protocol ID
- 18/NTB/161
- Acronym
- CETUS
- Status last verified
- Nov 2019
- First submitted
- 18 Mar 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Y, Kimita W, Bharmal SH, Petrov MS. Changes in apolipoproteins following ingestion of a beverage delivering beta-hydroxybutyrate: results from a randomized placebo-controlled trial. Front Nutr. 2026 Feb 5;12:1726174. doi: 10.3389/fnut.2025.1726174. eCollection 2025.
PubMed 41725999Charles 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.
PubMed 38927068Charles 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.
PubMed 36594212Liu 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.
PubMed 36565045Liu 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.
PubMed 35871064Bharmal 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.
PubMed 34024503Bharmal 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.
PubMed 33561274
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over, Placebo-controlled, Randomized Trial of β-hydroxybutyrate in Prediabetes
- ClinicalTrials.gov ID
- NCT03889210
- Acronym / sponsor ID
- CETUS / 18/NTB/161
- Conditions
- PreDiabetes
- Keywords
- Ketones, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVMN ketone drink | Active comparator | Other: HVMN KetoneHVMN ketone drink will be given in a total volume of 100 ml. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be given in a total volume of 100 ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals over 18 years
- Individuals diagnosed with prediabetes; defined based on the American Diabetes Association guidelines
- History of at least one episode of acute pancreatitis
- Written informed consent
Key exclusion criteria (5 listed)
- Individuals who are on a ketogenic diet or consuming nutritional ketone supplements
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HVMN KetoneWater-based, flavoured sport beverage | Other | HVMN ketone drink |
| PlaceboWater, stevia, malic acid, and thickening agent | Other | Placebo |
Primary outcome
Rate of change in plasma glucose concentration
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Changes in plasma glucose concentration before and after administration of the intervention/placebo
9 secondary outcomes
Rate of change in plasma insulin and C-peptide concentrations
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of gut and pancreatic hormones
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in lipid profile and digestive enzymes
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of pro-inflammatory cytokines
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Rate of change in plasma concentration of markers of iron metabolism
Time frame: Baseline, 30, 60, 90, 120, and 150 minutes
Correlation with body fat phenotypes
Time frame: 150 minutes
Correlation with body fat phenotypes
Time frame: 150 minutes
Correlation with body fat phenotypes
Time frame: 150 minutes
Correlation with physical activity
Time frame: 150 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Derived from this study: PubMed 41725999Liu Y, Kimita W, Bharmal SH, Petrov MS. Changes in apolipoproteins following ingestion of a beverage delivering beta-hydroxybutyrate: results from a randomized placebo-controlled trial. Front Nutr. 2026 Feb 5;12:1726174. doi: 10.3389/fnut.2025.1726174. eCollection 2025.
- Derived from this study: PubMed 38927068Charles 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.
- Derived from this study: PubMed 36594212Charles 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.
- Derived from this study: PubMed 36565045Liu 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.
- Derived from this study: PubMed 35871064Liu 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.
- Derived from this study: PubMed 34024503Bharmal 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.
- Derived from this study: PubMed 33561274Bharmal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HVMN Ketone in people with PreDiabetes, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in plasma glucose concentration (time frame: Baseline, 30, 60, 90, 120, and 150 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889210, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.