- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086381
Creatine Effect on Brown Adipose Tissue Activation (CreaBAT)
February 22, 2021 updated by: Patrick Schrauwen, Maastricht University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female;
- 18 to 30 years of age;
- Consuming a vegetarian diet;
- BMI 20-25 kg/m2.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention
Oral injestion of 20 grams of creatine monohydrate daily
|
5 grams of creatine monohydrate, four times daily, for 9 consecutive days.
|
Placebo Comparator: Placebo
Oral injestion of 20 grams of cellulose daily
|
oral ingestion of placebo containing 20 gram cellulose daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brown adipose tissue activation through 18F-FDG PET-MRI
Time Frame: Day 10 of protocol
|
Standard Uptake Value (SUV)
|
Day 10 of protocol
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet-induced thermogenesis through indirect calorimetry
Time Frame: Day 8 of protocol
|
Whole body energy expenditure in kJ/kg/min
|
Day 8 of protocol
|
Posphocreatine (PCr) Recovery through 31P-MRS
Time Frame: Day 9 of protocol
|
Halftime of PCr Recovery
|
Day 9 of protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
January 22, 2020
Study Completion (Actual)
January 22, 2020
Study Registration Dates
First Submitted
September 10, 2019
First Submitted That Met QC Criteria
September 10, 2019
First Posted (Actual)
September 11, 2019
Study Record Updates
Last Update Posted (Actual)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- NL64709.068.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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