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

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.

Study Overview

• Status: Unknown
• Conditions: Health Promotion; Primary Prevention
• Intervention / Treatment: Dietary supplement: HIIT + protein; Dietary supplement: HIIT + placebo; Dietary supplement: HIIT and resistance training + protein; Dietary supplement: HIIT and resistance training + placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hans J Herrmann, Dr.; Phone Number: +49 9131 8545218; Email: hans.herrmann@uk-erlangen.de

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Recruiting
    • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Aerobic exercise; Resistance training; Cardiorespiratory Fitness; High-intensity interval training (HIIT); Protein intake
• Other Study ID Numbers: PRO-HIIT Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No