Creatine Effect on Brown Adipose Tissue Activation (CreaBAT)

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
• Conditions: Diet-induced Thermogenesis; Brown Adipose Tissue Activation
• Intervention / Treatment: Dietary supplement: Creatine monohydrate; Dietary supplement: placebo cellulose

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229ER
      • Maastricht University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Oral injestion of 20 grams of creatine monohydrate daily	Dietary supplement: Creatine monohydrate; 5 grams of creatine monohydrate, four times daily, for 9 consecutive days.
Placebo Comparator: Placebo; Oral injestion of 20 grams of cellulose daily	Dietary supplement: placebo cellulose; 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	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

Collaborators and Investigators

• Sponsor: Maastricht University

Publications and helpful links

General 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.

Study record dates

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

• Keywords: Brown adipose tissue; Diet-induced thermogenesis; Creatine monohydrate
• 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