CreaBAT: Creatine Effect on Brown Adipose Tissue Activation

• Sponsor: Maastricht University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04086381
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diet-induced Thermogenesis; Brown Adipose Tissue Activation	Dietary Supplement: Creatine monohydrate; Dietary Supplement: placebo cellulose	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A double-blind, randomised, controlled, cross-over intervention trial.A double-blind, randomised, controlled, cross-over intervention trial.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Creatine Monohydrate Supplementation in Young, Healthy Vegetarian Adults and Its Effect on Brown Adipose Tissue Activation
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Jan 22, 2020
• Actual Study Completion Date: Jan 22, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Brown adipose tissue activation through 18F-FDG PET-MRI [Day 10 of protocol]

   Standard Uptake Value (SUV)

Secondary Outcome Measures

1. Diet-induced thermogenesis through indirect calorimetry [Day 8 of protocol]

   Whole body energy expenditure in kJ/kg/min

2. Posphocreatine (PCr) Recovery through 31P-MRS [Day 9 of protocol]

   Halftime of PCr Recovery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University	Maastricht	Limburg	Netherlands	6229ER

Sponsors and Collaborators

• Maastricht University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patrick Schrauwen, Principal Investigator, Maastricht University
• ClinicalTrials.gov Identifier: NCT04086381
• Other Study ID Numbers: NL64709.068.18
• First Posted: Sep 11, 2019
• Last Update Posted: Feb 24, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Patrick Schrauwen, Principal Investigator, Maastricht University: Brown adipose tissue; Creatine monohydrate; Diet-induced thermogenesis

Study Results

No Results Posted as of Feb 24, 2021