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

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ClinicalTrials.gov Identifier: NCT04086381
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Patrick Schrauwen, Maastricht University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vegetarian Diet

Arm Intervention/treatment
Active Comparator: Creatine monohydrate Dietary Supplement: Creatine monohydrate
5 grams of creatine monohydrate, four times daily, for 9 consecutive days.

Placebo Comparator: Placebo Dietary Supplement: Creatine monohydrate
5 grams of creatine monohydrate, four times daily, for 9 consecutive days.




Primary Outcome Measures :
  1. Brown adipose tissue activation [ Time Frame: Day 10 of protocol ]
    SUVmean and SUVmax


Secondary Outcome Measures :
  1. Diet-induced thermogenesis [ Time Frame: Day 8 of protocol ]
    whole body energy expenditure in kJ/kg/min

  2. PCr Recovery [ Time Frame: Day 9 of protocol ]
    Halftime



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086381


Locations
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Netherlands
Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 6229ER
Contact: Niels Connell, MSc    +31433881587    n.connell@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University

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Responsible Party: Patrick Schrauwen, Prof. Dr., Maastricht University
ClinicalTrials.gov Identifier: NCT04086381     History of Changes
Other Study ID Numbers: NL64709.068.18
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick Schrauwen, Maastricht University:
Brown adipose tissue
Creatine monohydrate
Diet-induced thermogenesis