Do High Doses of Protein Supplements Affect Serum Lipid Profiles?

To Study the Effects of Protein Supplements on Blood Tests Clinical Trial

Official title:

Do High Doses of Protein Supplements Affect Serum Lipid Profiles?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170036
• Other study ID #: 2019-1-001
• Status: Completed
• Start date: March 15, 2019
• Est. completion date: August 20, 2019

Study information

• Verified date: November 2019
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. So the investigators aimed to investigate this subject and compare the blood tests between subjects using and not using protein supplements.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 20, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• To Study the Effects of Protein Supplements on Blood Tests

Intervention

Dietary Supplement:
• protein supplement
Protein supplement usage for at least three preceding months in varied amounts

Locations

Country	Name	City	State
Cyprus	Near East University	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Cyprus, 

References & Publications (1)

Salgueiro RB, Gerlinger-Romero F, Guimarães-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum glucose level	mg/dl	1 day
Primary	Serum insulin level	uU/ml	1 day
Primary	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	No unit	1 day
Primary	Serum hemoglobine level	g/dl	1 day
Primary	Serum mean platelet volume	fL	1 day
Primary	Serum platelet level	x10^3/uL	1 day
Primary	Serum creatinine level	mg/dl	1 day
Primary	Serum urea level	mg/dl	1 day
Primary	Serum uric acid level	mg/dl	1 day
Primary	Serum aspartate aminotransferase level	U/L	1 day
Primary	Serum alanine aminotransferase level	U/L	1 day
Primary	Serum gama-glutamile transferase level	U/L	1 day
Primary	Serum sodium level	mmol/L	1 day
Primary	Serum potassium level	mmol/L	1 day
Primary	Serum calcium level	mg/dl	1 day
Primary	Serum magnesium level	mg/dl	1 day
Primary	Serum total cholesterol level	mg/dl	1 day
Primary	Serum high-density lipoprotein level	mg/dl	1 day
Primary	Serum low-density lipoprotein level	mg/dl	1 day
Primary	Serum triglyceride level	mg/dl	1 day
Primary	Serum C-reactive protein level	mg/dl	1 day