NCT04007731

Brief Summary

Post-exercise nutrition is an important factor in a nutrition plan for physically active subjects. Focusing on that, the Serbian group is developing protein bars enriched with sports supplements. Slovenian partner group will investigate the effect of new protein bar consumption on body composition, biochemical parameters, and muscle regeneration after training. The new bar will be compared with a commercially available bar.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

June 21, 2019

Last Update Submit

March 23, 2020

Conditions

Keywords

protein barphysical activitymuscle

Outcome Measures

Primary Outcomes (2)

  • Muscle mass

    Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).

    15 days

  • Fat mass

    Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).

    15 days

Secondary Outcomes (4)

  • C-reactive protein

    15 days

  • Creatine kinase

    15 days

  • Lactate dehydrogenase

    15 days

  • Tumor necrosis factor alpha

    15 days

Study Arms (2)

High protein, high fibre and creatine load bar (DrRip)

EXPERIMENTAL

1 new protein bar (260 kcal) after training every day

Dietary Supplement: DrRip - high protein, high fibre and creatine load

Voltage energy bar

ACTIVE COMPARATOR

1 control commercially available protein bar (260 kcal) after training every day

Dietary Supplement: Voltage energy bar

Interventions

A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption

Also known as: Protein product
High protein, high fibre and creatine load bar (DrRip)
Voltage energy barDIETARY_SUPPLEMENT

A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption

Also known as: control protein bar
Voltage energy bar

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • daily high-intensity physical activity

You may not qualify if:

  • smoking, cardiovascular, neurological, skeletal muscle disease, allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, SI-6310, Slovenia

Location

MeSH Terms

Conditions

InflammationMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 21, 2019

First Posted

July 5, 2019

Study Start

July 1, 2019

Primary Completion

December 5, 2019

Study Completion

February 20, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Other researchers on the study (Saša Kenig, Ana Petelin, Tadeja Jakus) will analyze samples, which will be coded by PI

Locations