Clinical trial NCT04170036: Do High Doses of Protein Supplements Affect Serum Lipid Profiles?
Official title: Do High Doses of Protein Supplements Affect Serum Lipid Profiles?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Study the Effects of Protein Supplements on Blood Tests
Keywords: Protein supplement
Serum creatinine
Serum sodium
Glucose metabolism
Lipid profile
C-reactive protein
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 69
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy population going to the gym for at least three preceding months

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

- Going to the gym for at least three preceding months

Exclusion Criteria:

* 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

Primary outcomes:
measure: Serum glucose level
timeFrame: 1 day
measure: Serum insulin level
timeFrame: 1 day
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: 1 day
measure: Serum hemoglobine level
timeFrame: 1 day
measure: Serum mean platelet volume
timeFrame: 1 day
measure: Serum platelet level
timeFrame: 1 day
measure: Serum creatinine level
timeFrame: 1 day
measure: Serum urea level
timeFrame: 1 day
measure: Serum uric acid level
timeFrame: 1 day
measure: Serum aspartate aminotransferase level
timeFrame: 1 day
measure: Serum alanine aminotransferase level
timeFrame: 1 day
measure: Serum gama-glutamile transferase level
timeFrame: 1 day
measure: Serum sodium level
timeFrame: 1 day
measure: Serum potassium level
timeFrame: 1 day
measure: Serum calcium level
timeFrame: 1 day
measure: Serum magnesium level
timeFrame: 1 day
measure: Serum total cholesterol level
timeFrame: 1 day
measure: Serum high-density lipoprotein level
timeFrame: 1 day
measure: Serum low-density lipoprotein level
timeFrame: 1 day
measure: Serum triglyceride level
timeFrame: 1 day
measure: Serum C-reactive protein level
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Near East University
Study officials:
affiliation: Near East University Cardiology Department
name: Umit Yuksek, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.