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Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04359342
Enrollment
100
Registered
2020-04-24
Start date
2020-01-01
Completion date
2022-12-31
Last updated
2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Promotion, Primary Prevention

Keywords

Aerobic exercise, Cardiorespiratory Fitness, High-intensity interval training (HIIT), Resistance training, Protein intake

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.

Interventions

DIETARY_SUPPLEMENTHIIT + 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.

DIETARY_SUPPLEMENTHIIT + 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.

DIETARY_SUPPLEMENTHIIT 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.

DIETARY_SUPPLEMENTHIIT 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.

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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).

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiorespiratory Fitness (CRF)8 weeksCRF will be assessed by measuring maximum oxygen uptake (VO2max)
Muscle strength (only in groups with resistance training)8 weeksMaximum 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.

Secondary

MeasureTime frameDescription
Cardiometabolic Risk Score (MetS-Z-Score)8 weeksMetS-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.
Muscle mass8 weeksMuscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Fat mass8 weeksFat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Insulin sensitivity8 weeksInsulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
Inflammation status8 weeksInflammation status will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP)
Health-related quality of life8 weeksHealth-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).

Countries

Germany

Contacts

Primary ContactDejan Reljic, Dr.
dejan.reljic@uk-erlangen.de+49 9131 8545218
Backup ContactHans J Herrmann, Dr.
hans.herrmann@uk-erlangen.de+49 9131 8545218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026