Creatine Effect on Brown Adipose Tissue Activation

Diet-induced Thermogenesis Clinical Trial

— CreaBAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086381
• Other study ID #: NL64709.068.18
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: January 22, 2020

Study information

• Verified date: February 2021
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brown Adipose Tissue Activation
• Diet-induced Thermogenesis

Intervention

Dietary Supplement:
• Creatine monohydrate
5 grams of creatine monohydrate, four times daily, for 9 consecutive days.
• placebo cellulose
oral ingestion of placebo containing 20 gram cellulose daily

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brown adipose tissue activation through 18F-FDG PET-MRI	Standard Uptake Value (SUV)	Day 10 of protocol
Secondary	Diet-induced thermogenesis through indirect calorimetry	Whole body energy expenditure in kJ/kg/min	Day 8 of protocol
Secondary	Posphocreatine (PCr) Recovery through 31P-MRS	Halftime of PCr Recovery	Day 9 of protocol