Creatine Effect on Brown Adipose Tissue Activation

Study Overview
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Brief Summary
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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.

Official Title
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Creatine Monohydrate Supplementation in Young, Healthy Vegetarian Adults and Its Effect on Brown Adipose Tissue Activation

Conditions
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Diet-induced Thermogenesis, Brown Adipose Tissue Activation

Intervention / Treatment
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* Dietary Supplement: Creatine monohydrate
* Dietary Supplement: placebo cellulose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A double-blind, randomised, controlled, cross-over intervention trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Oral injestion of 20 grams of creatine monohydrate daily | Dietary Supplement: Creatine monohydrate<br>* 5 grams of creatine monohydrate, four times daily, for 9 consecutive days.<br>|
| Placebo Comparator: Placebo<br>Oral injestion of 20 grams of cellulose daily | Dietary Supplement: placebo cellulose<br>* oral ingestion of placebo containing 20 gram cellulose daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brown adipose tissue activation through 18F-FDG PET-MRI | Standard Uptake Value (SUV) | Day 10 of protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet-induced thermogenesis through indirect calorimetry | Whole body energy expenditure in kJ/kg/min | Day 8 of protocol | 
| Posphocreatine (PCr) Recovery through 31P-MRS | Halftime of PCr Recovery | Day 9 of protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brown adipose tissue, Creatine monohydrate, Diet-induced thermogenesis