Do High Doses of Protein Supplements Affect Serum Lipid Profiles?

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.

Study Overview

• Status: Completed
• Conditions: To Study the Effects of Protein Supplements on Blood Tests
• Intervention / Treatment: Dietary supplement: protein supplement

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 Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus, 99138
    • Near East University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Healthy population going to the gym for at least three preceding months

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Protein supplement group; The group of subjects who use protein supplements at least for the preceding three months	Dietary supplement: protein supplement; Protein supplement usage for at least three preceding months in varied amounts
Control group; The group of subjects who never used protein supplements

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Near East University, Turkey
• Investigators: Principal Investigator: Umit Yuksek, Dr., Near East University Cardiology Department

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): August 15, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Lipid profile; C-reactive protein; Protein supplement; Glucose metabolism; Serum creatinine; Serum sodium
• Other Study ID Numbers: 2019-1-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The subjects participated in the study do not want this.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No