Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness

Health Promotion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04359342
• Other study ID #: PRO-HIIT Study
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Dejan Reljic, Dr.
• Phone: +49 9131 8545218
• Email: dejan.reljic[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Promotion
• Primary Prevention

Intervention

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.
• 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.
• 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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory Fitness (CRF)	CRF will be assessed by measuring maximum oxygen uptake (VO2max)	8 weeks
Primary	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	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
Secondary	Muscle mass	Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)	8 weeks
Secondary	Fat mass	Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)	8 weeks
Secondary	Insulin sensitivity	Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)	8 weeks
Secondary	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
Secondary	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