Primary PreventionNCT04359342
Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness
A study testing HIIT + protein and HIIT and resistance training + protein in people with Primary Prevention and Health Promotion, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention, Health Promotion
- What is being tested?
- HIIT + protein and HIIT and resistance training + protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary Lifestyle over at least 6 months prior to the study
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, 91052
Dejan Reljic, Dr., +49 9131 8545218, dejan.reljic@uk-erlangen.de
Yurdaguel Zopf, Prof., +49 9131 8545218, yurdaguel.zopf@uk-erlangen.de
About this study
Official title: 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.
- Conditions
- Primary Prevention, Health Promotion
- Being tested
- HIIT + protein, HIIT + placebo, HIIT and resistance training + protein, HIIT and resistance training + placebo
- Keywords
- Aerobic exercise, Cardiorespiratory Fitness, High-intensity interval training (HIIT), Resistance training, Protein intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT + proteinDietary supplement
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.
HIIT + placeboDietary supplement
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.
HIIT and resistance training + proteinDietary supplement
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.
HIIT and resistance training + placeboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| HIIT + protein | Experimental | High-intensity interval training (HIIT) combined with protein supplementation Receives: Dietary Supplement: HIIT + protein |
| HIIT + placebo | Placebo comparator | High-intensity interval training (HIIT) combined with placebo Receives: Dietary Supplement: HIIT + placebo |
| HIIT and resistance training + protein | Experimental | High-intensity interval training (HIIT) and resistance training combined with protein supplementation Receives: Dietary Supplement: HIIT and resistance training + protein |
| HIIT and resistance training + placebo | Placebo comparator | High-intensity interval training (HIIT) and resistance training combined with placebo Receives: Dietary Supplement: HIIT and resistance training + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness (CRF)
CRF will be assessed by measuring maximum oxygen uptake (VO2max)
Measured: 8 weeks
Muscle strength (only in groups with resistance training)
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.
Measured: 8 weeks
Secondary outcomes (6)
Cardiometabolic Risk Score (MetS-Z-Score)
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.
Measured: 8 weeks
Muscle mass
Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Measured: 8 weeks
Fat mass
Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Measured: 8 weeks
Insulin sensitivity
Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
Measured: 8 weeks
Inflammation status
Inflammation status will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP)
Measured: 8 weeks
Health-related quality of life
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Parallel Assignment parallel-group, randomized, double-blind, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dejan Reljic, Dr., Principal investigator, University Erlangen Nuremberg Medical SchoolYurdagül Zopf, Prof., Principal investigator, University Erlangen Nuremberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359342
- Sponsor's protocol ID
- PRO-HIIT Study
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Interval Training Combined With Post-exercise Protein Supplementation on Cardiorespiratory Fitness in Untrained Individuals: a Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04359342
- Acronym / sponsor ID
- PRO-HIIT Study
- Conditions
- Primary Prevention, Health Promotion
- Keywords
- Aerobic exercise, Cardiorespiratory Fitness, High-intensity interval training (HIIT), Resistance training, Protein intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment Parallel Assignment parallel-group, randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| HIIT + protein | Experimental | Dietary Supplement: HIIT + proteinHigh-intensity interval training (HIIT) combined with protein supplementation |
| HIIT + placebo | Placebo comparator | Dietary Supplement: HIIT + placeboHigh-intensity interval training (HIIT) combined with placebo |
| HIIT and resistance training + protein | Experimental | Dietary Supplement: HIIT and resistance training + proteinHigh-intensity interval training (HIIT) and resistance training combined with protein supplementation |
| HIIT and resistance training + placebo | Placebo comparator | Dietary Supplement: HIIT and resistance training + placeboHigh-intensity interval training (HIIT) and resistance training combined with placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sedentary Lifestyle over at least 6 months prior to the study
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT + protein8-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. | Dietary supplement | HIIT + protein |
| HIIT + placebo8-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. | Dietary supplement | HIIT + placebo |
| HIIT and resistance training + protein8-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. | Dietary supplement | HIIT and resistance training + protein |
| HIIT and resistance training + placebo8-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. | Dietary supplement | HIIT and resistance training + placebo |
Primary outcome
Cardiorespiratory Fitness (CRF)
Time frame: 8 weeks
CRF will be assessed by measuring maximum oxygen uptake (VO2max)
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.
6 secondary outcomes
Cardiometabolic Risk Score (MetS-Z-Score)
Time frame: 8 weeks
Muscle mass
Time frame: 8 weeks
Fat mass
Time frame: 8 weeks
Insulin sensitivity
Time frame: 8 weeks
Inflammation status
Time frame: 8 weeks
Health-related quality of life
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dejan Reljic, Dr. principal investigator
University Erlangen Nuremberg Medical School
Yurdagül Zopf, Prof. principal investigator
University Erlangen Nuremberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT + protein and HIIT and resistance training + protein in people with Primary Prevention and Health Promotion, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dejan Reljic, Dr. (+49 9131 8545218, dejan.reljic@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (CRF) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.