The main objective of this study is to determine whether creatine monohydrate supplementation enhances diet-induced thermogenesis and brown adipose tissue activity in young, healthy adults, as quantified through PET-MR, following an acute cold…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
energiemetabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
SUVmean and SUVmax of brown adipose tissue depots as determined by PET-MR using
the 18F-FDG tracer.
Secondary outcome
- Diet-induced thermogenesis;
- Ex vivo mitochondrial respiration in skeletal muscle;
- In vivo mitochondrial function in skeletal muscle
- Blood and muscle creatine;
- Blood metabolites;
- Body composition;
- Metabolic substrate handling;
- Molecular pathways and gene transcription putatively responsible for
triggering improved mitochondrial health and function.
Background 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 important 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.
Study objective
The main objective of this study is to determine whether creatine monohydrate
supplementation enhances diet-induced thermogenesis and brown adipose tissue
activity in young, healthy adults, as quantified through PET-MR, following an
acute cold exposure.
Study design
A double-blind, randomised, controlled, cross-over intervention trial, in which
creatine monohydrate supplementation will be compared to placebo.
Intervention
Creatine monohydrate will be supplemented at 5 grams four times daily.
Study burden and risks
This study will lead to novel insights with respect to the effect of creatine
monohydrate on diet-induced thermogenesis and the activation of brown adipose
tissue in humans. However, this study is not expected to be directly beneficial
to the participants. The major burden to the subjects is a time investment.
Subjects will be asked to attend the university on, in total, 7 occasions for
measurement procedures. Additionally, subjects will be asked to consume
creatine monohydrate versus placebo on a daily basis for a period of 9 days
each. The experimental procedures are without risks, except for blood sampling
and sampling of muscle and white adipose tissue biopsies, which can
occasionally cause a local hematoma or bruising. The risk of infection or
prolonged bleeding is low due to state of the art techniques and sterility
measures. Measurements performed during the time course of the study can
potentially lead to coincidental medical findings. Subjects will be informed
about such a finding and possibly be advised to contact their own physician
about this.
Universiteitssingel 50
Maastricht 6200 MD
NL
Universiteitssingel 50
Maastricht 6200 MD
NL
Listed location countries
Age
Inclusion criteria
- Male or female;
- Caucasian;
- 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 preceding year.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64709.068.18 |
| Other | volgt z.s.m. |