Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness

April 21, 2020 updated by: University of Erlangen-Nürnberg Medical School

Effects of High-intensity Interval Training Combined With Post-exercise Protein Supplementation on Cardiorespiratory Fitness in Untrained Individuals: a Double-blind Placebo-controlled Trial

The aim of this study is to investigate the effects of an 8-week high-intensity interval training (HIIT) or HIIT plus resistance training program combined with post-exercise protein supplementation on cardiorespiratory fitness and cardiometabolic risk indices in previously untrained individuals.

Study Overview

Status

Status

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

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.

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.
Interventional

Enrollment (Anticipated)

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.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Recruiting
        • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

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 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Sedentary Lifestyle over at least 6 months prior to the study

Exclusion Criteria:

  • Pregnancy, Lactation
  • Psychological disorders, epilepsy, sever neurological disorders
  • Participation in other exercise- or nutrition studies within the last 6 months
  • coronary heart disease, heart failure
  • malignant disease
  • severe rheumatic or neurological disease
  • severe/unstable hypertension (resting RR: >180/>110 mmHg)
  • severely restricted lung function (FEV1 <60%)
  • unstable Diabetes mellitus
  • severe orthopedic disease/restriction
  • acute / chronic infectious diseases
  • Electronic implants (defibrillator, pacemaker)
  • Persons in mental hospitals by order of authorities or jurisdiction

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
EXPERIMENTAL: HIIT + protein
High-intensity interval training (HIIT) combined with protein supplementation
Dietary supplement: HIIT + protein

8-week supervised exercise program consisting of high-intensity interval training (HIIT).

HIIT: 10x1 min at 85-95% HRmax divided by low intensity recovery periods. Three exercise sessions per week. Participants receive 40 g of a commercially available protein supplement administered as a shake after every exercise session.
PLACEBO_COMPARATOR: HIIT + placebo
High-intensity interval training (HIIT) combined with placebo
Dietary supplement: HIIT + placebo

8-week supervised exercise program consisting of high-intensity interval training (HIIT).

HIIT: 10x1 min at 85-95% HRmax divided by low intensity recovery periods. Three exercise sessions per week. Participants receive 40 g of a commercially available iso-caloric placebo (Maltodextrin) administered as a shake after every exercise session.
EXPERIMENTAL: HIIT and resistance training + protein
High-intensity interval training (HIIT) and resistance training combined with protein supplementation
Dietary supplement: HIIT and resistance training + protein

8-week supervised exercise program consisting of high-intensity interval training (HIIT) and resistance training (RST).

HIIT: 5x1 min at 85-95% HRmax divided by low intensity recovery periods. RST: 3-set resistance training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum. Two exercise sessions per week. Participants receive 40 g of a commercially available protein supplement administered as a shake after every exercise session.
PLACEBO_COMPARATOR: HIIT and resistance training + placebo
High-intensity interval training (HIIT) and resistance training combined with placebo
Dietary supplement: HIIT and resistance training + placebo

8-week supervised exercise program consisting of high-intensity interval training (HIIT) and resistance training (RST).

HIIT: 5x1 min at 85-95% HRmax divided by low intensity recovery periods. RST: 3-set resistance training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum. Two exercise sessions per week. Participants receive 40 g of a commercially available iso-caloric placebo (Maltodextrin) administered as a shake after every exercise session.

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
Cardiorespiratory Fitness (CRF)
Time Frame: 8 weeks
CRF will be assessed by measuring maximum oxygen uptake (VO2max)
8 weeks
Muscle strength (only in groups with resistance training)
Time Frame: 8 weeks
Maximum strength (Fmax) of the major muscle groups (chest, upper back, lower back, abdominals and legs) will be estimated through submaximal tests, based on the performance of multiple repetitions.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiometabolic Risk Score (MetS-Z-Score)
Time Frame: 8 weeks
MetS-Z-Score will be calculated from each individual's measures of waist circumference (cm), mean arterial blood pressure (mmHg), Glucose (mg/dL), triglycerides (mg/dL), and HDL-cholesterol (mg/dL), based on equations specific to sex.
8 weeks
Muscle mass
Time Frame: 8 weeks
Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
8 weeks
Fat mass
Time Frame: 8 weeks
Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
8 weeks
Insulin sensitivity
Time Frame: 8 weeks
Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
8 weeks
Inflammation status
Time Frame: 8 weeks
Inflammation status will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP)
8 weeks
Health-related quality of life
Time Frame: 8 weeks

Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire, consisting of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

The patient ticks the box next to the most appropriate statement in each dimension (scale: 1-5; lower value = better outcome). The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state.The EQ VAS records the patient's self-rated health on a vertical visual analogue scale (0-100, higher value = better outcome).
8 weeks

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.
University of Erlangen-Nürnberg Medical School

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.
January 1, 2020

Primary Completion (ANTICIPATED)

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.
December 31, 2022

Study Completion (ANTICIPATED)

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.
December 31, 2022

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).
April 21, 2020

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.
April 21, 2020

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.
April 24, 2020

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.
April 24, 2020

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.
April 21, 2020

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.
April 1, 2020

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.
  • PRO-HIIT Study

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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