Clinical trial NCT04086381: Creatine Effect on Brown Adipose Tissue Activation
Official title: Creatine Monohydrate Supplementation in Young, Healthy Vegetarian Adults and Its Effect on Brown Adipose Tissue Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet-induced Thermogenesis
Brown Adipose Tissue Activation
Keywords: Brown adipose tissue
Creatine monohydrate
Diet-induced thermogenesis
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A double-blind, randomised, controlled, cross-over intervention trial.
Primary purpose: BASIC_SCIENCE

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brown adipose tissue activation through 18F-FDG PET-MRI
timeFrame: Day 10 of protocol
Secondary outcomes:
measure: Diet-induced thermogenesis through indirect calorimetry
timeFrame: Day 8 of protocol
measure: Posphocreatine (PCr) Recovery through 31P-MRS
timeFrame: Day 9 of protocol
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
citation: 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.