Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Recruiting

CT.gov ID

NCT04359342

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Prevention Health Promotion	Dietary Supplement: HIIT + protein Dietary Supplement: HIIT + placebo Dietary Supplement: HIIT and resistance training + protein Dietary Supplement: HIIT and resistance training + placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, 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).

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Cardiorespiratory Fitness (CRF) [8 weeks]
CRF will be assessed by measuring maximum oxygen uptake (VO2max)
Muscle strength (only in groups with resistance training) [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.

Secondary Outcome Measures

Cardiometabolic Risk Score (MetS-Z-Score) [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.
Muscle mass [8 weeks]
Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Fat mass [8 weeks]
Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Insulin sensitivity [8 weeks]
Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
Inflammation status [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)
Health-related quality of life [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg	Erlangen		Germany	91052

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School

Investigators

Principal Investigator: Dejan Reljic, Dr., University Erlangen Nuremberg Medical School
Principal Investigator: Yurdagül Zopf, Prof., University Erlangen Nuremberg Medical School