Creatine Effect on Brown Adipose Tissue Activation

NCT04086381 | Completed

• 1 other identifier: NL64709.068.18
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet-induced Thermogenesis; Brown Adipose Tissue Activation

Keywords

Brown adipose tissue; Creatine monohydrate; Diet-induced thermogenesis

Outcome Measures

Primary Outcomes (1)

• Brown adipose tissue activation through 18F-FDG PET-MRI

  Standard Uptake Value (SUV)

  Day 10 of protocol

Secondary Outcomes (2)

• Diet-induced thermogenesis through indirect calorimetry

  Day 8 of protocol

• Posphocreatine (PCr) Recovery through 31P-MRS

  Day 9 of protocol

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Oral injestion of 20 grams of creatine monohydrate daily

Dietary Supplement: Creatine monohydrate

Placebo

PLACEBO COMPARATOR

Oral injestion of 20 grams of cellulose daily

Dietary Supplement: placebo cellulose

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

5 grams of creatine monohydrate, four times daily, for 9 consecutive days.

Intervention

placebo cellulose DIETARY_SUPPLEMENT

oral ingestion of placebo containing 20 gram cellulose daily

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female;
• to 30 years of age;
• Consuming a vegetarian diet;
• BMI 20-25 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33462512 DERIVED

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blind, randomised, controlled, cross-over intervention trial.

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 11, 2019
• Study Start: May 1, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)