Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness

Study Overview
=================
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.

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

Conditions
-----------------
Primary Prevention, Health Promotion

Intervention / Treatment
-----------------
* Dietary Supplement: HIIT + protein
* Dietary Supplement: HIIT + placebo
* Dietary Supplement: HIIT and resistance training + protein
* Dietary Supplement: HIIT and resistance training + placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment Parallel Assignment parallel-group, randomized, double-blind, placebo-controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIIT + protein<br>High-intensity interval training (HIIT) combined with protein supplementation | Dietary Supplement: HIIT + protein<br>* 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.<br>|
| Placebo Comparator: HIIT + placebo<br>High-intensity interval training (HIIT) combined with placebo | Dietary Supplement: HIIT + placebo<br>* 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.<br>|
| Experimental: HIIT and resistance training + protein<br>High-intensity interval training (HIIT) and resistance training combined with protein supplementation | Dietary Supplement: HIIT and resistance training + protein<br>* 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.<br>|
| Placebo Comparator: HIIT and resistance training + placebo<br>High-intensity interval training (HIIT) and resistance training combined with placebo | Dietary Supplement: HIIT and resistance training + placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| Muscle mass | Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA) | 8 weeks | 
| Fat mass | Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA) | 8 weeks | 
| Insulin sensitivity | Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA) | 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) | 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). | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aerobic exercise, Cardiorespiratory Fitness, High-intensity interval training (HIIT), Resistance training, Protein intake