ObesityNCT03729934
Ketones Supplementation and Postprandial Lipemia
A study testing Ketone Ester and Ketone Salt in people with Obesity and Overweight and Obesity, run by University of Alabama at Birmingham.
Trial summary
This study determines whether different forms of ketones supplemented prior to a meal lower the triglyceride (fat) content in the blood of overweight and obese individuals. Through a randomized crossover design, participants (n=15) will participate in each of the following three experimental groups (no treatment… Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight and Obesity, Overweight
- What is being tested?
- Ketone Ester and Ketone Salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jan 2021
- 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 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight or obese men as defined by a BMI of greater than or equal to 25 kg/m2, but less than 35 kg/m2
- Between the ages of 25 and 45 years
- Fasting triglyceride levels less than 250 mg/dL
Who cannot join
- Participates in regular physical activity (≥3 days/week at 30 minutes or more per day)
- Diagnosed cardiovascular disease or metabolic disease (type 1 or type 2 diabetes)
- Currently following a low carbohydrate (<100 g/day) diet
- Lost greater than or equal to 5% body weight over the last 2 months
- Alcohol/smoking/antibiotics
About this study
Official title: Effects of Ketones Supplementation on Postprandial Lipemia
This study determines whether different forms of ketones supplemented prior to a meal lower the triglyceride (fat) content in the blood of overweight and obese individuals. Through a randomized crossover design, participants (n=15) will participate in each of the following three experimental groups (no treatment control, ketone ester, ketone salt), with a 5-14 day washout period between each experimental visit.
Read the detailed description
Previous studies conducted by the investigative team in rodents show that male mice fed a diet containing 30% ketone ester (by kcals) results in greater fecal content and energy loss. While the investigators are unsure of the exact macronutrient content of the energy loss, the hypothesis is that the energy excretion is attributed to lower fat absorption. In the context of this study, it's hypothesized that ketone salts and ketone esters (both available commercially and used for a variety of health-related claims) will reduce the absorption of dietary fats leading to lower circulating triglyceride concentrations if consumed prior to a high-fat mixed meal. If the hypothesis is correct, ketones supplementation could become a valuable strategy to reduce the rise in circulating triglycerides often present in obesity. Triglyceride concentrations in the blood following a meal have been linked to development of cardiovascular disease.
- Conditions
- Obesity, Overweight and Obesity, Overweight, Triglycerides High
- Being tested
- Ketone Ester, Ketone Salt
- Medical subject headings
- Obesity, Overweight, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone EsterDietary supplement
This arm receives 25 g ketone ester.
Ketone SaltDietary supplement
This arm receives 25 g ketone salt.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm receives no treatment control. |
| Ketone Ester | Experimental | This arm receives 25 g ketone ester. Receives: Dietary Supplement: Ketone Ester |
| Ketone Salt | Experimental | This arm receives 25 g ketone salt. Receives: Dietary Supplement: Ketone Salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline plasma glucagon-like peptide 1 at 240 minutes
Plasma levels of glucagon-like peptide 1 in pg/L
Measured: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline serum triglycerides at 240 minutes
Serum levels of triglycerides in mg/DL
Measured: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline serum glucose at 240 minutes
Serum levels of glucose in mg/dL
Measured: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline serum Insulin at 240 minutes
Serum levels of insulin in pmol/L
Measured: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline serum B-hydroxybutyrate at 240 minutes
Serum levels of B-hydroxybutyrate in mmol/L
Measured: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline plasma ghrelin at 240 minutes
Plasma levels of ghrelin in pg/mL
Measured: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Change from baseline plasma leptin at 240 minutes
Plasma levels of leptin in ng/mL
Measured: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Dec 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021
Why it stopped: Dissertation for student changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric P. Plaisance, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729934
- Sponsor's protocol ID
- KBS2018
- Status last verified
- Apr 2021
- First submitted
- 23 Oct 2018
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketones Supplementation on Postprandial Lipemia
- ClinicalTrials.gov ID
- NCT03729934
- Acronym / sponsor ID
- KBS2018
- Conditions
- Obesity, Overweight and Obesity, Overweight, Triglycerides High
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Dissertation for student changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 5 Nov 2018 (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 determines whether different forms of ketones supplemented prior to a meal lower the triglyceride (fat) content in the blood of overweight and obese individuals. Through a randomized crossover design, participants (n=15) will participate in each of the following three experimental groups (no treatment control, ketone ester, ketone salt), with a 5-14 day washout period between each experimental visit.
Detailed description
Previous studies conducted by the investigative team in rodents show that male mice fed a diet containing 30% ketone ester (by kcals) results in greater fecal content and energy loss. While the investigators are unsure of the exact macronutrient content of the energy loss, the hypothesis is that the energy excretion is attributed to lower fat absorption. In the context of this study, it's hypothesized that ketone salts and ketone esters (both available commercially and used for a variety of health-related claims) will reduce the absorption of dietary fats leading to lower circulating triglyceride concentrations if consumed prior to a high-fat mixed meal. If the hypothesis is correct, ketones supplementation could become a valuable strategy to reduce the rise in circulating triglycerides often present in obesity. Triglyceride concentrations in the blood following a meal have been linked to development of cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm receives no treatment control. |
| Ketone Ester | Experimental | Dietary Supplement: Ketone EsterThis arm receives 25 g ketone ester. |
| Ketone Salt | Experimental | Dietary Supplement: Ketone SaltThis arm receives 25 g ketone salt. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overweight or obese men as defined by a BMI of greater than or equal to 25 kg/m2, but less than 35 kg/m2
- Between the ages of 25 and 45 years
- Fasting triglyceride levels less than 250 mg/dL
Key exclusion criteria (5 listed)
- Participates in regular physical activity (≥3 days/week at 30 minutes or more per day)
- Diagnosed cardiovascular disease or metabolic disease (type 1 or type 2 diabetes)
- Currently following a low carbohydrate (<100 g/day) diet
- Lost greater than or equal to 5% body weight over the last 2 months
- Alcohol/smoking/antibiotics
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 |
|---|---|---|
| Ketone EsterThis arm receives 25 g ketone ester. | Dietary supplement | Ketone Ester |
| Ketone SaltThis arm receives 25 g ketone salt. | Dietary supplement | Ketone Salt |
Primary outcome
Change from baseline plasma glucagon-like peptide 1 at 240 minutes
Time frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Plasma levels of glucagon-like peptide 1 in pg/L
Change from baseline serum triglycerides at 240 minutes
Time frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Serum levels of triglycerides in mg/DL
Change from baseline serum glucose at 240 minutes
Time frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Serum levels of glucose in mg/dL
Change from baseline serum Insulin at 240 minutes
Time frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Serum levels of insulin in pmol/L
Change from baseline serum B-hydroxybutyrate at 240 minutes
Time frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Serum levels of B-hydroxybutyrate in mmol/L
Change from baseline plasma ghrelin at 240 minutes
Time frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Plasma levels of ghrelin in pg/mL
Change from baseline plasma leptin at 240 minutes
Time frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption
Plasma levels of leptin in ng/mL
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Ester and Ketone Salt in people with Obesity and Overweight and Obesity, run by University of Alabama at Birmingham.
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 3 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: withdrawn, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 from baseline plasma glucagon-like peptide 1 at 240 minutes (time frame: 0, 30, 60, 120, 180, and 240 minutes post-supplement consumption). The study lists 7 primary outcomes in all. 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 4 May 2021.