Creatine Effect on Brown Adipose Tissue Activation

NCT ID: NCT04086381

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-01-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Oral injestion of 20 grams of creatine monohydrate daily

Group Type: ACTIVE_COMPARATOR

Creatine monohydrate

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Oral injestion of 20 grams of cellulose daily

Group Type: PLACEBO_COMPARATOR

placebo cellulose

Intervention Type: DIETARY_SUPPLEMENT

oral ingestion of placebo containing 20 gram cellulose daily

Interventions

Creatine monohydrate

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

Intervention Type: DIETARY_SUPPLEMENT

placebo cellulose

oral ingestion of placebo containing 20 gram cellulose daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University

OTHER

Sponsor Role: lead

Responsible Party

Patrick Schrauwen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maastricht University

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 33462512 (View on PubMed)

Other Identifiers

NL64709.068.18

Identifier Type: -

Identifier Source: org_study_id