To Study the Effects of Protein Supplements on Blood TestsNCT04170036
Do High Doses of Protein Supplements Affect Serum Lipid Profiles?
An observational study of To Study the Effects of Protein Supplements on Blood Tests, run by Near East University, Turkey at 1 site in Cyprus.
Trial summary
Protein supplements are widely used among people going to the gym. The effects of these substances on blood biochemical, hematological, inflammatuary, glucose metabolism markers and lipid profile is not well known. The previous studies on this issue give inconclusive results. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- To Study the Effects of Protein Supplements on Blood Tests
- What is being tested?
- protein supplement
- How many people
- 69 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Mar 2019to 20 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy population going to the gym for at least three preceding months
Who may be able to join
- Going to the gym for at least three preceding months
Who cannot join
- Any kind of acute or chronic illness
- Abnormality on electrocardiography
- Body-mass index>30 kg/m2
- Use of any kind of drugs
- Hypertension at the time of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Protein supplements are widely used among people going to the gym. The effects of these substances on blood biochemical, hematological, inflammatuary, glucose metabolism markers and lipid profile is not well known. The previous studies on this issue give inconclusive results. So the investigators aimed to investigate this subject and compare the blood tests between subjects using and not using protein supplements.
Read the detailed description
As more people are doing regular exercises, people using protein supplements are also increasing. The effects of these substances on blood lipid profiles, biochemical, hematological parameters, inflammatory and glucose metabolism markers are not well known. So the investigators of this study planned to search the effects of these substances on blood tests. Totally 69 subjects going to the gym for at least three preceding months were included to the study. They were divided into two groups: the ones using protein supplements and the ones who never used these substances. Demographic and clinical characteristics were recorded. Dietician assessed the dietary habits of the subjects. Blood was drawn for the tests mentioned above from all of the subjects. And the results were compared between the two groups.
- Being tested
- protein supplement
- Keywords
- Protein supplement, Serum creatinine, Serum sodium, Glucose metabolism, Lipid profile, C-reactive protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementDietary supplement
Protein supplement usage for at least three preceding months in varied amounts
| Study group | Role | What they receive |
|---|---|---|
| Protein supplement group | The group of subjects who use protein supplements at least for the preceding three months Receives: Dietary Supplement: protein supplement | |
| Control group | The group of subjects who never used protein supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum glucose level
mg/dl
Measured: 1 day
Serum insulin level
uU/ml
Measured: 1 day
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
No unit
Measured: 1 day
Serum hemoglobine level
g/dl
Measured: 1 day
Serum mean platelet volume
fL
Measured: 1 day
Serum platelet level
x10^3/uL
Measured: 1 day
Serum creatinine level
mg/dl
Measured: 1 day
Serum urea level
mg/dl
Measured: 1 day
Serum uric acid level
mg/dl
Measured: 1 day
Serum aspartate aminotransferase level
U/L
Measured: 1 day
Serum alanine aminotransferase level
U/L
Measured: 1 day
Serum gama-glutamile transferase level
U/L
Measured: 1 day
Serum sodium level
mmol/L
Measured: 1 day
Serum potassium level
mmol/L
Measured: 1 day
Serum calcium level
mg/dl
Measured: 1 day
Serum magnesium level
mg/dl
Measured: 1 day
Serum total cholesterol level
mg/dl
Measured: 1 day
Serum high-density lipoprotein level
mg/dl
Measured: 1 day
Serum low-density lipoprotein level
mg/dl
Measured: 1 day
Serum triglyceride level
mg/dl
Measured: 1 day
Serum C-reactive protein level
mg/dl
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start15 Mar 2019
- Primary completion15 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Study the Effects of Protein Supplements on Blood TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umit Yuksek, Near East University, Turkey
- Investigators
- Umit Yuksek, Dr., Principal investigator, Near East University Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170036
- Sponsor's protocol ID
- 2019-1-001
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The subjects participated in the study do not want this.
Publications
Salgueiro RB, Gerlinger-Romero F, Guimaraes-Ferreira L, de Castro Barbosa T, Nunes MT. Exercise training reverses the negative effects of chronic L-arginine supplementation on insulin sensitivity. Life Sci. 2017 Dec 15;191:17-23. doi: 10.1016/j.lfs.2017.10.001. Epub 2017 Oct 7.
PubMed 28993146
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do High Doses of Protein Supplements Affect Serum Lipid Profiles?
- ClinicalTrials.gov ID
- NCT04170036
- Acronym / sponsor ID
- 2019-1-001
- Keywords
- Protein supplement, Serum creatinine, Serum sodium, Glucose metabolism, Lipid profile, C-reactive protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protein supplements are widely used among people going to the gym. The effects of these substances on blood biochemical, hematological, inflammatuary, glucose metabolism markers and lipid profile is not well known. The previous studies on this issue give inconclusive results. So the investigators aimed to investigate this subject and compare the blood tests between subjects using and not using protein supplements.
Detailed description
As more people are doing regular exercises, people using protein supplements are also increasing. The effects of these substances on blood lipid profiles, biochemical, hematological parameters, inflammatory and glucose metabolism markers are not well known. So the investigators of this study planned to search the effects of these substances on blood tests. Totally 69 subjects going to the gym for at least three preceding months were included to the study. They were divided into two groups: the ones using protein supplements and the ones who never used these substances. Demographic and clinical characteristics were recorded. Dietician assessed the dietary habits of the subjects. Blood was drawn for the tests mentioned above from all of the subjects. And the results were compared between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein supplement group | – | Dietary Supplement: protein supplementThe group of subjects who use protein supplements at least for the preceding three months |
| Control group | – | –The group of subjects who never used protein supplements |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy population going to the gym for at least three preceding months
Key inclusion criteria (1 listed)
- Going to the gym for at least three preceding months
Key exclusion criteria (5 listed)
- Any kind of acute or chronic illness
- Abnormality on electrocardiography
- Body-mass index>30 kg/m2
- Use of any kind of drugs
- Hypertension at the time of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein supplementProtein supplement usage for at least three preceding months in varied amounts | Dietary supplement | Protein supplement group |
Primary outcome
Serum glucose level
Time frame: 1 day
mg/dl
Serum insulin level
Time frame: 1 day
uU/ml
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 1 day
No unit
Serum hemoglobine level
Time frame: 1 day
g/dl
Serum mean platelet volume
Time frame: 1 day
fL
Serum platelet level
Time frame: 1 day
x10^3/uL
Serum creatinine level
Time frame: 1 day
mg/dl
Serum urea level
Time frame: 1 day
mg/dl
Serum uric acid level
Time frame: 1 day
mg/dl
Serum aspartate aminotransferase level
Time frame: 1 day
U/L
Serum alanine aminotransferase level
Time frame: 1 day
U/L
Serum gama-glutamile transferase level
Time frame: 1 day
U/L
Serum sodium level
Time frame: 1 day
mmol/L
Serum potassium level
Time frame: 1 day
mmol/L
Serum calcium level
Time frame: 1 day
mg/dl
Serum magnesium level
Time frame: 1 day
mg/dl
Serum total cholesterol level
Time frame: 1 day
mg/dl
Serum high-density lipoprotein level
Time frame: 1 day
mg/dl
Serum low-density lipoprotein level
Time frame: 1 day
mg/dl
Serum triglyceride level
Time frame: 1 day
mg/dl
Serum C-reactive protein level
Time frame: 1 day
mg/dl
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 28993146Salgueiro RB, Gerlinger-Romero F, Guimaraes-Ferreira L, de Castro Barbosa T, Nunes MT. Exercise training reverses the negative effects of chronic L-arginine supplementation on insulin sensitivity. Life Sci. 2017 Dec 15;191:17-23. doi: 10.1016/j.lfs.2017.10.001. Epub 2017 Oct 7.
- Individual participant dataSharing planned: No. The subjects participated in the study do not want this.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umit Yuksek, Dr. principal investigator
Near East University Cardiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Study the Effects of Protein Supplements on Blood Tests, run by Near East University, Turkey at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum glucose level (time frame: 1 day). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04170036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.