NCT04359342

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

April 21, 2020

Last Update Submit

April 21, 2020

Conditions

Primary PreventionHealth Promotion

Keywords

Aerobic exerciseCardiorespiratory FitnessHigh-intensity interval training (HIIT)Resistance trainingProtein intake

Outcome Measures

Primary Outcomes (2)

  • Cardiorespiratory Fitness (CRF)

    CRF will be assessed by measuring maximum oxygen uptake (VO2max)

    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.

    8 weeks

Secondary Outcomes (6)

  • Cardiometabolic Risk Score (MetS-Z-Score)

    8 weeks

  • Muscle mass

    8 weeks

  • Fat mass

    8 weeks

  • Insulin sensitivity

    8 weeks

  • Inflammation status

    8 weeks

  • +1 more secondary outcomes

Study Arms (4)

HIIT + protein

EXPERIMENTAL

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

Dietary Supplement: HIIT + protein

HIIT + placebo

PLACEBO COMPARATOR

High-intensity interval training (HIIT) combined with placebo

Dietary Supplement: HIIT + placebo

HIIT and resistance training + protein

EXPERIMENTAL

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

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

Dietary Supplement: HIIT and resistance training + placebo

Interventions

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 + protein
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 + placebo
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 + protein
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.

HIIT and resistance training + placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, 91052, Germany

RECRUITING

MeSH Terms

Interventions

ProteinsResistance Training

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dejan Reljic, Dr.

    University Erlangen Nuremberg Medical School

    PRINCIPAL INVESTIGATOR

  • Yurdagül Zopf, Prof.

    University Erlangen Nuremberg Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dejan Reljic, Dr.

CONTACT

+49 9131 8545218dejan.reljic@uk-erlangen.de

Hans J Herrmann, Dr.

CONTACT

+49 9131 8545218hans.herrmann@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment Parallel Assignment parallel-group, randomized, double-blind, placebo-controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

DE(1)