Diet-induced ThermogenesisCreaBATNCT04086381
Creatine Effect on Brown Adipose Tissue Activation
A study testing Creatine monohydrate in people with Diet-induced Thermogenesis and Brown Adipose Tissue Activation, run by Maastricht University at 1 site in Netherlands.
Trial summary
Pre-clinical studies indicate that creatine may play a substantial role in diet-induced thermogenesis and may have a profound effect on energy balance. A recent retrospective study of BAT activation on PET-CT scans in humans showed a positive association with the estimated renal creatinine clearance and BAT… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet-induced Thermogenesis, Brown Adipose Tissue Activation
- What is being tested?
- Creatine monohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2018to 22 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female;
- 18 to 30 years of age;
- Consuming a vegetarian diet;
- BMI 20-25 kg/m2.
Who cannot join
- Not meeting all inclusion criteria;
- Non-vegetarian diet;
- Excessive alcohol and/or drug abuse;
- Significant allergies or intolerances concerning the study products;
- Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
- Medication use known to hamper subject's safety during the study procedures;
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- Subjects with contra-indications for MRI and/or PET-CT;
- Subjects who do not want to be informed about unexpected medical findings;
- Subjects who do not want that their treating physician to be informed;
- Co-morbidities to which the intervention or program that may pose as a complicating factor;
- Inability to participate and/or complete the required measurements;
- PET-CT scan in the last 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creatine Monohydrate Supplementation in Young, Healthy Vegetarian Adults and Its Effect on Brown Adipose Tissue Activation
Pre-clinical studies indicate that creatine may play a substantial role in diet-induced thermogenesis and may have a profound effect on energy balance. A recent retrospective study of BAT activation on PET-CT scans in humans showed a positive association with the estimated renal creatinine clearance and BAT activation, possibly linking creatine metabolism in humans to BAT activity. In humans, so far little options are available to activate brown adipose tissue. The most potent intervention to activate BAT is via cold, which has previously been shown to have metabolic effects in humans. Provided the potential health benefits of brown adipose tissue activation in humans, and provided the role of brown fat in diet induced thermogenesis, we here aim to determine whether creatine monohydrate supplementation can increase diet-induced thermogenesis and activate brown adipose tissue in humans.
- Being tested
- Creatine monohydrate, placebo cellulose
- Keywords
- Brown adipose tissue, Creatine monohydrate, Diet-induced thermogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDietary supplement
5 grams of creatine monohydrate, four times daily, for 9 consecutive days.
placebo celluloseDietary supplement
oral ingestion of placebo containing 20 gram cellulose daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Oral injestion of 20 grams of creatine monohydrate daily Receives: Dietary Supplement: Creatine monohydrate |
| Placebo | Placebo comparator | Oral injestion of 20 grams of cellulose daily Receives: Dietary Supplement: placebo cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brown adipose tissue activation through 18F-FDG PET-MRI
Standard Uptake Value (SUV)
Measured: Day 10 of protocol
Secondary outcomes (2)
Diet-induced thermogenesis through indirect calorimetry
Whole body energy expenditure in kJ/kg/min
Measured: Day 8 of protocol
Posphocreatine (PCr) Recovery through 31P-MRS
Halftime of PCr Recovery
Measured: Day 9 of protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 May 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet-induced ThermogenesisStudies 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
- A double-blind, randomised, controlled, cross-over intervention trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schrauwen, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086381
- Sponsor's protocol ID
- NL64709.068.18
- Acronym
- CreaBAT
- Status last verified
- Feb 2021
- First submitted
- 10 Sep 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Connell NJ, Doligkeit D, Andriessen C, Kornips-Moonen E, Bruls YMH, Schrauwen-Hinderling VB, van de Weijer T, van Marken-Lichtenbelt WD, Havekes B, Kazak L, Spiegelman BM, Hoeks J, Schrauwen P. No evidence for brown adipose tissue activation after creatine supplementation in adult vegetarians. Nat Metab. 2021 Jan;3(1):107-117. doi: 10.1038/s42255-020-00332-0. Epub 2021 Jan 18.
PubMed 33462512
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Monohydrate Supplementation in Young, Healthy Vegetarian Adults and Its Effect on Brown Adipose Tissue Activation
- ClinicalTrials.gov ID
- NCT04086381
- Acronym / sponsor ID
- CreaBAT / NL64709.068.18
- Keywords
- Brown adipose tissue, Creatine monohydrate, Diet-induced thermogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 11 Sep 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.
Pre-clinical studies indicate that creatine may play a substantial role in diet-induced thermogenesis and may have a profound effect on energy balance. A recent retrospective study of BAT activation on PET-CT scans in humans showed a positive association with the estimated renal creatinine clearance and BAT activation, possibly linking creatine metabolism in humans to BAT activity. In humans, so far little options are available to activate brown adipose tissue. The most potent intervention to activate BAT is via cold, which has previously been shown to have metabolic effects in humans. Provided the potential health benefits of brown adipose tissue activation in humans, and provided the role of brown fat in diet induced thermogenesis, we here aim to determine whether creatine monohydrate supplementation can increase diet-induced thermogenesis and activate brown adipose tissue in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A double-blind, randomised, controlled, cross-over intervention trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Creatine monohydrateOral injestion of 20 grams of creatine monohydrate daily |
| Placebo | Placebo comparator | Dietary Supplement: placebo celluloseOral injestion of 20 grams of cellulose daily |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female;
- 18 to 30 years of age;
- Consuming a vegetarian diet;
- BMI 20-25 kg/m2.
Key exclusion criteria (12 listed)
- Not meeting all inclusion criteria;
- Non-vegetarian diet;
- Excessive alcohol and/or drug abuse;
- Significant allergies or intolerances concerning the study products;
- Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
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 |
|---|---|---|
| Creatine monohydrate5 grams of creatine monohydrate, four times daily, for 9 consecutive days. | Dietary supplement | Intervention |
| placebo celluloseoral ingestion of placebo containing 20 gram cellulose daily | Dietary supplement | Placebo |
Primary outcome
Brown adipose tissue activation through 18F-FDG PET-MRI
Time frame: Day 10 of protocol
Standard Uptake Value (SUV)
2 secondary outcomes
Diet-induced thermogenesis through indirect calorimetry
Time frame: Day 8 of protocol
Posphocreatine (PCr) Recovery through 31P-MRS
Time frame: Day 9 of protocol
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 24 Feb 2021.
- Derived from this study: PubMed 33462512Connell NJ, Doligkeit D, Andriessen C, Kornips-Moonen E, Bruls YMH, Schrauwen-Hinderling VB, van de Weijer T, van Marken-Lichtenbelt WD, Havekes B, Kazak L, Spiegelman BM, Hoeks J, Schrauwen P. No evidence for brown adipose tissue activation after creatine supplementation in adult vegetarians. Nat Metab. 2021 Jan;3(1):107-117. doi: 10.1038/s42255-020-00332-0. Epub 2021 Jan 18.
- 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 Creatine monohydrate in people with Diet-induced Thermogenesis and Brown Adipose Tissue Activation, run by Maastricht University at 1 site in Netherlands.
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 12 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 24 Feb 2021. 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 Netherlands. 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?
Brown adipose tissue activation through 18F-FDG PET-MRI (time frame: Day 10 of protocol). 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 NCT04086381, which also lists 1 linked publication.
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 24 Feb 2021.