Cardiac OutputNCT04037722
Echocardiographic Changes After 3-hydroxy Butyrate+Whey Intake
A study testing Whey and 3-OHB + Whey in people with Cardiac Output and Endotoxemia, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study evaluates the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during human endotoxemia. Further, this study compares cardiovascular changes during healthy and catabolic conditions. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output, Endotoxemia, Catabolic State
- What is being tested?
- Whey and 3-OHB + Whey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Jun 2019to 23 Jan 2020
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20-40 years of age
- Body mass index between 20-30 kg/m^2
- Healthy
- Oral and written consent forms obtained prior to study day
Who cannot join
- Recent immobilization of an extremity that is not fully rehabilitated
- Lactose, lidocain or rubber allergies
- Current disease
- Use of anabolic steroids
- Smoking
- Former major abdominal surgery (Or current problems with the GI tract)
Show all 10Show fewer
- •>10 hours of exercise/weak
- Present ketogenic diets or high-protein diets
- Blood doner that does not want to discontinue blood donations until study completion
- Pending MR scan
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Research Labarotory, DoH, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Echocardiographic Changes After Oral Intake of 3-hydroxy Butyrate+Whey in a Human Endotoxemia Model
This study evaluates the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during human endotoxemia. Further, this study compares cardiovascular changes during healthy and catabolic conditions.
Participants will receive isocaloric, isonitrogenous beverages of either whey or 3-OHB+whey in a randomized crossover design during either healthy (overnight fast) or catabolic conditions (inflammation/endotoxemia + 36 h fast and bed rest).
Read the detailed description
Background: A newly published study found beneficial cardiovascular effects of 3-OHB infusion in a population with chronic heart failure, significantly increasing cardiac output. Similar effects on cardiac output were observed in healthy volunteers. These findings pave the way for 3-OHB as a therapeutic nutritional supplement, since it is well-absorbed during oral consumption. However, it is unknown whether the cardiovascular effects of 3-OHB persist during a sepsis-like catabolic state and when administered orally.
Aim: This study aims to investigate the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during a human disease model, comprising endotoxemia + bed rest + fast.
Hypothesis:
- Adding the ketone body 3-OHB to an oral protein supplement increases cardiac output measures
- Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces cardiovascular changes compared with healthy conditions (overnight fast) Interventions: In a randomized crossover design, eight healthy, lean, young men will undergo either:
- Healthy conditions (overnight fast) + whey protein^ ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest*) + whey protein^ iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest*) + 3-OHB/whey protein^" *LPS will be administered (1 ng/kg) the day prior to the study together with fast and bed rest. On the study day LPS (0.5 ng/kg) will be injected. ^Beverages will be isonitrogenous and isocaloric (fat will be added) with 45 g whey protein + 20 g maltodextrin. Bolus/sip administration will be applied (1/3 bolus, 1/2 sip) " 50 grams of 3-OHB will be orally administered (1/2 bolus, 1/2 sip)
- Conditions
- Cardiac Output, Endotoxemia, Catabolic State, Echocardiography
- Being tested
- Whey, 3-OHB + Whey
- Keywords
- Cardiac Output, Endotoxemia, Ketone bodies, 3-hydroxy butyrate, Whey protein, Catabolic State
- Medical subject headings
- Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WheyDietary supplement
45 g whey + 20 g maltodextrin
3-OHB + WheyDietary supplement
50 g ketone + 45 g whey + 20 g maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Healthy + Whey | Experimental | Healthy conditions (overnight fast) Receives: Dietary Supplement: Whey |
| Catabolic + Whey | Experimental | Catabolic conditions (36-hour fast, bed rest and inflammation (LPS)) Receives: Dietary Supplement: Whey |
| Catabolic + 3-OHB / Whey | Experimental | Catabolic conditions (36-hour fast, bed rest and inflammation (LPS)) Receives: Dietary Supplement: 3-OHB + Whey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular outflow tract velocity time integral
Echocardiographic changes in left ventricular outflow tract velocity time integral from the basal period and after 1.5 hours of intervention
Measured: Measured during the basal period and after 1.5 hours of intervention
Secondary outcomes (12)
Changes in Left Ventricular Ejection Fraction (LVEF)
Echocardiographic changes in LVEF from the basal period and after 1.5 hours of intervention
Measured: Measured during the basal period and after 1.5 hours of intervention
Changes in Global Longitudinal Strain (GLS)
Echocardiographic changes in GLS from the basal period and after 1.5 hours of intervention
Measured: Measured during the basal period and after 1.5 hours of intervention
Changes in S´ Max
Echocardiographic changes in S´ Max from the basal period and after 1.5 hours of intervention
Measured: Measured during the basal period and after 1.5 hours of intervention
Changes in blood pressure
Changes in blood pressure from the basal period and after 1.5 hours of intervention
Measured: Measured during the basal period and after 1.5 hours of intervention
Changes in heart rate
Changes in heart rate from the basal period and after 1.5 hours of intervention
Measured: Measured during the basal period and after 1.5 hours of intervention
Changes in axillary temperature
Changes in axillary temperature from the basal period and after 1.5 hours of intervention
Measured: Measured during the basal period and after 1.5 hours of intervention
Difference in Left Ventricular Ejection Fraction (LVEF) (Healthy vs catabolic conditions)
Echocardiographic difference in LVEF during the basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: Measured after 2 hours of basal period
Difference in Global Longitudinal Strain (GLS) (Healthy vs catabolic conditions)
Echocardiographic difference in GLS during the basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: Measured after 2 hours of basal period
Difference in S´ Max (Healthy vs catabolic conditions)
Echocardiographic difference in S´ Max during the basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: Measured after 2 hours of basal period
Difference in axillary temperature (healthy vs catabolic)
Difference in axillary temperature after 2 hours basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: Measured after 2 hours of basal period
Difference in heart rate (healthy vs catabolic)
Difference in heart rate after 2 hours basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: Measured after 2 hours of basal period
Difference in blood pressure (healthy vs catabolic)
Difference in blood pressure after 2 hours basal period between healthy and catabolic conditions (a pooled mean of the two catabolic days, if there is no difference between the first and second time of LPS exposure)
Measured: Measured after 2 hours of basal period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start17 Jun 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a randomized crossover design, eight healthy lean young men will undergo either: i) Healthy conditions (overnight fast) + whey protein ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest) + whey protein iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest) + 3-OHB/whey protein
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods, Aarhus University Hospital Skejby
- Responsible party
- Sponsor
- Investigators
- Niels Moeller, Professor, Principal investigator, Aarhus University Hospital and Institute of Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037722
- Sponsor's protocol ID
- Ketone Heart Study
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Changes After Oral Intake of 3-hydroxy Butyrate+Whey in a Human Endotoxemia Model
- ClinicalTrials.gov ID
- NCT04037722
- Acronym / sponsor ID
- Ketone Heart Study
- Conditions
- Cardiac Output, Endotoxemia, Catabolic State, Echocardiography
- Keywords
- Cardiac Output, Endotoxemia, Ketone bodies, 3-hydroxy butyrate, Whey protein, Catabolic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Arla Foods, Aarhus University Hospital Skejby
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 30 Jul 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.
This study evaluates the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during human endotoxemia. Further, this study compares cardiovascular changes during healthy and catabolic conditions.
Participants will receive isocaloric, isonitrogenous beverages of either whey or 3-OHB+whey in a randomized crossover design during either healthy (overnight fast) or catabolic conditions (inflammation/endotoxemia + 36 h fast and bed rest).
Detailed description
Background: A newly published study found beneficial cardiovascular effects of 3-OHB infusion in a population with chronic heart failure, significantly increasing cardiac output. Similar effects on cardiac output were observed in healthy volunteers. These findings pave the way for 3-OHB as a therapeutic nutritional supplement, since it is well-absorbed during oral consumption. However, it is unknown whether the cardiovascular effects of 3-OHB persist during a sepsis-like catabolic state and when administered orally.
Aim: This study aims to investigate the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during a human disease model, comprising endotoxemia + bed rest + fast.
Hypothesis:
- Adding the ketone body 3-OHB to an oral protein supplement increases cardiac output measures
- Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces cardiovascular changes compared with healthy conditions (overnight fast) Interventions: In a randomized crossover design, eight healthy, lean, young men will undergo either:
- Healthy conditions (overnight fast) + whey protein^ ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest*) + whey protein^ iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest*) + 3-OHB/whey protein^" *LPS will be administered (1 ng/kg) the day prior to the study together with fast and bed rest. On the study day LPS (0.5 ng/kg) will be injected. ^Beverages will be isonitrogenous and isocaloric (fat will be added) with 45 g whey protein + 20 g maltodextrin. Bolus/sip administration will be applied (1/3 bolus, 1/2 sip) " 50 grams of 3-OHB will be orally administered (1/2 bolus, 1/2 sip)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- In a randomized crossover design, eight healthy lean young men will undergo either: i) Healthy conditions (overnight fast) + whey protein ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest) + whey protein iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest) + 3-OHB/whey protein
| Arm | Type | Receives |
|---|---|---|
| Healthy + Whey | Experimental | Dietary Supplement: WheyHealthy conditions (overnight fast) |
| Catabolic + Whey | Experimental | Dietary Supplement: WheyCatabolic conditions (36-hour fast, bed rest and inflammation (LPS)) |
| Catabolic + 3-OHB / Whey | Experimental | Dietary Supplement: 3-OHB + WheyCatabolic conditions (36-hour fast, bed rest and inflammation (LPS)) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 20-40 years of age
- Body mass index between 20-30 kg/m^2
- Healthy
- Oral and written consent forms obtained prior to study day
Key exclusion criteria (10 listed)
- Recent immobilization of an extremity that is not fully rehabilitated
- Lactose, lidocain or rubber allergies
- Current disease
- Use of anabolic steroids
- Smoking
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 |
|---|---|---|
| Whey45 g whey + 20 g maltodextrin | Dietary supplement | Catabolic + Whey, Healthy + Whey |
| 3-OHB + Whey50 g ketone + 45 g whey + 20 g maltodextrin | Dietary supplement | Catabolic + 3-OHB / Whey |
Primary outcome
Change in left ventricular outflow tract velocity time integral
Time frame: Measured during the basal period and after 1.5 hours of intervention
Echocardiographic changes in left ventricular outflow tract velocity time integral from the basal period and after 1.5 hours of intervention
12 secondary outcomes
Changes in Left Ventricular Ejection Fraction (LVEF)
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in Global Longitudinal Strain (GLS)
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in S´ Max
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in blood pressure
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in heart rate
Time frame: Measured during the basal period and after 1.5 hours of intervention
Changes in axillary temperature
Time frame: Measured during the basal period and after 1.5 hours of intervention
Difference in Left Ventricular Ejection Fraction (LVEF) (Healthy vs catabolic conditions)
Time frame: Measured after 2 hours of basal period
Difference in Global Longitudinal Strain (GLS) (Healthy vs catabolic conditions)
Time frame: Measured after 2 hours of basal period
Difference in S´ Max (Healthy vs catabolic conditions)
Time frame: Measured after 2 hours of basal period
Difference in axillary temperature (healthy vs catabolic)
Time frame: Measured after 2 hours of basal period
Difference in heart rate (healthy vs catabolic)
Time frame: Measured after 2 hours of basal period
Difference in blood pressure (healthy vs catabolic)
Time frame: Measured after 2 hours of basal period
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 11 Jun 2020.
- 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.
Niels Moeller, Professor principal investigator
Aarhus University Hospital and Institute of Clinical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey and 3-OHB + Whey in people with Cardiac Output and Endotoxemia, run by University of Aarhus at 1 site in Denmark.
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 10 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 11 Jun 2020. 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 Denmark. 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. 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?
Change in left ventricular outflow tract velocity time integral (time frame: Measured during the basal period and after 1.5 hours of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020; AzTrials last refreshed its copy on 30 Oct 2026.