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OpenTrials
Completed

NCT Number: NCT04086381

Creatine 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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

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

placebo cellulose

Dietary Supplement

oral ingestion of placebo containing 20 gram cellulose daily

Primary outcomes

  1. Brown adipose tissue activation through 18F-FDG PET-MRI

    Time frame: Day 10 of protocol

    Standard Uptake Value (SUV)

Secondary outcomes

  1. Diet-induced thermogenesis through indirect calorimetry

    Time frame: Day 8 of protocol

    Whole body energy expenditure in kJ/kg/min

  2. Posphocreatine (PCr) Recovery through 31P-MRS

    Time frame: Day 9 of protocol

    Halftime of PCr Recovery

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Official study title

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

Acronym: CreaBAT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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