Do High Doses of Protein Supplements Affect Serum Lipid Profiles?

November 19, 2019 updated by: Umit Yuksek, Near East University, Turkey
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum glucose level
Time Frame: 1 day
mg/dl
1 day
Serum insulin level
Time Frame: 1 day
uU/ml
1 day
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: 1 day
No unit
1 day
Serum hemoglobine level
Time Frame: 1 day
g/dl
1 day
Serum mean platelet volume
Time Frame: 1 day
fL
1 day
Serum platelet level
Time Frame: 1 day
x10^3/uL
1 day
Serum creatinine level
Time Frame: 1 day
mg/dl
1 day
Serum urea level
Time Frame: 1 day
mg/dl
1 day
Serum uric acid level
Time Frame: 1 day
mg/dl
1 day
Serum aspartate aminotransferase level
Time Frame: 1 day
U/L
1 day
Serum alanine aminotransferase level
Time Frame: 1 day
U/L
1 day
Serum gama-glutamile transferase level
Time Frame: 1 day
U/L
1 day
Serum sodium level
Time Frame: 1 day
mmol/L
1 day
Serum potassium level
Time Frame: 1 day
mmol/L
1 day
Serum calcium level
Time Frame: 1 day
mg/dl
1 day
Serum magnesium level
Time Frame: 1 day
mg/dl
1 day
Serum total cholesterol level
Time Frame: 1 day
mg/dl
1 day
Serum high-density lipoprotein level
Time Frame: 1 day
mg/dl
1 day
Serum low-density lipoprotein level
Time Frame: 1 day
mg/dl
1 day
Serum triglyceride level
Time Frame: 1 day
mg/dl
1 day
Serum C-reactive protein level
Time Frame: 1 day
mg/dl
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Near East University, Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Umit Yuksek, Dr., Near East University Cardiology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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