Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness

Not Applicable

• Conditions: Health Promotion; Primary Prevention
• Interventions: Dietary Supplement: HIIT and resistance training + placebo; Dietary Supplement: HIIT + placebo; Dietary Supplement: HIIT and resistance training + protein; Dietary Supplement: HIIT + protein

• Registration Number: NCT04359342
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIIT and resistance training + placebo	HIIT and resistance training + placebo	High-intensity interval training (HIIT) and resistance training combined with placebo
HIIT + placebo	HIIT + placebo	High-intensity interval training (HIIT) combined with placebo
HIIT and resistance training + protein	HIIT and resistance training + protein	High-intensity interval training (HIIT) and resistance training combined with protein supplementation
HIIT + protein	HIIT + protein	High-intensity interval training (HIIT) combined with protein supplementation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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)
Insulin sensitivity	8 weeks	Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
Fat mass	8 weeks	Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
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)

Trial Locations

Locations (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany