Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness

NCT ID: NCT04359342

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Prevention Health Promotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Parallel Assignment parallel-group, randomized, double-blind, placebo-controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Randomized, double-blind placebo-controlled study. Participants and Outcome Assessors will not be aware of the arm to which the participants are allocated (double-blinded masking).

Study Groups

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HIIT + protein

High-intensity interval training (HIIT) combined with protein supplementation

Group Type EXPERIMENTAL

HIIT + protein

Intervention Type DIETARY_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 + placebo

High-intensity interval training (HIIT) combined with placebo

Group Type PLACEBO_COMPARATOR

HIIT + placebo

Intervention Type DIETARY_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 + protein

High-intensity interval training (HIIT) and resistance training combined with protein supplementation

Group Type EXPERIMENTAL

HIIT and resistance training + protein

Intervention Type DIETARY_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 + placebo

High-intensity interval training (HIIT) and resistance training combined with placebo

Group Type PLACEBO_COMPARATOR

HIIT and resistance training + placebo

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dejan Reljic, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Yurdagül Zopf, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Locations

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

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Dejan Reljic, Dr.

Role: CONTACT

+49 9131 8545218

Hans J Herrmann, Dr.

Role: CONTACT

+49 9131 8545218

Facility Contacts

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Dejan Reljic, Dr.

Role: primary

+49 9131 8545218

Yurdaguel Zopf, Prof.

Role: backup

+49 9131 8545218

Other Identifiers

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PRO-HIIT Study

Identifier Type: -

Identifier Source: org_study_id

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