Effect of Carbohydrate-protein Co-ingestion on Short-term Recovery

Sponsor

Erica Goldstein (Other)

Overall Status

Completed

CT.gov ID

NCT04859491

Collaborator

(none)

Enrollment

Location

Arms

4.5

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the consumption of a carbohydrate, carbohydrate plus protein, or placebo sports drink during a 2-hour recovery period effectively moderates performance decrements during a subsequent bout of high-intensity exercise. This information will benefit any endurance-trained masters class athlete who may need to compete or train multiple times a day.

Condition or Disease	Intervention/Treatment	Phase
Dietary Supplementations	Dietary Supplement: Carbohydrate Dietary Supplement: Carbohydrate-Protein Dietary Supplement: Placebo	N/A

Detailed Description

To test the hypothesis, this study will utilize a randomized, double-blind, placebo-controlled between-subject design to examine the effects of carbohydrate (CHO) and carbohydrate-protein (CHO-P) supplementation on short-term recovery following aerobic interval exercise (INT) and time to exhaustion (TTE) testing in maters class athletes. After completing the informed consent and screening process (Visit #1), each participant will be assessed for their anthropometric measures as well as body composition and will complete a graded exercise test to volitional exhaustion on a cycle ergometer to determine VO2peak. Forty-eight to 72 hours after Visit #1, or VO2peak testing, participants will return to the lab for familiarization with the INT exercise protocol and TTE test (Visit #2). Within forty-eight to 72 hours after familiarization (Visit #2), participants will return to the lab for Visit #3 to complete INT exercise and TTE, a 2-hour passive recovery period including the consumption of one of three treatments (CHO, CHO-P, PLA), followed by repeated INT exercise and TTE, heart rate variability and sweat rate determination. Participants will also complete the Nutritional Recovery Practices, Knowledge, and Beliefs of Australian Triathletes survey during the 2-hour recovery period. Participants will be asked to complete the ASA24®, an automated self-administered 24-hour dietary assessment tool during the 5-9-day period between familiarization (Visit #2) and the experimental protocol (Visit #3).

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized to one of three groups: isocaloric carbohydrate (1.2 g/kg of body weight), carbohydrate-protein (0.8 g/kg body weight carbohydrate + 0.4 g/kg body weight protein), or placebo (flavored water). All three beverages will have a similar appearance and taste and participants will be blinded to the contents. All beverages will contain the same volume of fluid (1 liter).Participants will be randomized to one of three groups: isocaloric carbohydrate (1.2 g/kg of body weight), carbohydrate-protein (0.8 g/kg body weight carbohydrate + 0.4 g/kg body weight protein), or placebo (flavored water). All three beverages will have a similar appearance and taste and participants will be blinded to the contents. All beverages will contain the same volume of fluid (1 liter).

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The primary investigator will not be blinded to the treatment groups. However, both the research assistants responsible for administering the experimental protocol (aerobic interval and time to exhaustion testing) and the participants will be.

Primary Purpose:

Other

Official Title:

Effects of Post-Exercise Recovery Drink Composition on Subsequent Performance in Masters Class Athletes

Actual Study Start Date :

Jul 22, 2021

Actual Primary Completion Date :

Dec 5, 2021

Actual Study Completion Date :

Dec 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Carbohydrate Carbohydrate in the amount of 1.2 g/kg of body weight (bw). Gatorade®, Chicago, IL, USA.	Dietary Supplement: Carbohydrate Participants have a one in three chance of consuming a carbohydrate beverage between two bouts of high-intensity exercise. Other Names: CHO
Active Comparator: Carbohydrate-Protein Carbohydrate in the amount of 0.8 g/kg bw (Gatorade®, Chicago, IL, USA) plus protein in the amount of 0.4 g/kg bw (biPro Elite, Agropur Inc., Appleton, WI, USA).	Dietary Supplement: Carbohydrate-Protein Participants have a one in three chance of consuming a carbohydrate-protein beverage between two bouts of high-intensity exercise. Other Names: CHO-P
Placebo Comparator: Placebo Flavored water (G Zero, Gatorade®, Chicago, IL, USA).	Dietary Supplement: Placebo Participants have a one in three chance of consuming a placebo beverage between two bouts of high-intensity exercise. Other Names: PLA

Arm

Intervention/Treatment

Active Comparator: Carbohydrate

Carbohydrate in the amount of 1.2 g/kg of body weight (bw). Gatorade®, Chicago, IL, USA.

Dietary Supplement: Carbohydrate

Participants have a one in three chance of consuming a carbohydrate beverage between two bouts of high-intensity exercise.

Other Names:

CHO

Active Comparator: Carbohydrate-Protein

Carbohydrate in the amount of 0.8 g/kg bw (Gatorade®, Chicago, IL, USA) plus protein in the amount of 0.4 g/kg bw (biPro Elite, Agropur Inc., Appleton, WI, USA).

Dietary Supplement: Carbohydrate-Protein

Participants have a one in three chance of consuming a carbohydrate-protein beverage between two bouts of high-intensity exercise.

Other Names:

CHO-P

Placebo Comparator: Placebo

Flavored water (G Zero, Gatorade®, Chicago, IL, USA).

Dietary Supplement: Placebo

Participants have a one in three chance of consuming a placebo beverage between two bouts of high-intensity exercise.

Other Names:

PLA

Outcome Measures

Primary Outcome Measures

Time to Exhaustion (TTE) [Visit #3 (Day 7)]
Participants cycle for as long as possible at 90% of peak power output (watts)

Secondary Outcome Measures

Heart Rate Variability (HRV) [Visit #3 (Day 7)]
R-R intervals recorded via a heart rate monitor and Elite HRV will be downloaded and analyzed using a laptop with commercially available HRV analysis software. Root mean square of the successive differences of R-R intervals (RMSSD) values will be recorded during the 90% TTE and then post-exercise every 5 min (end of TTE, 5min, 10min, 15min, 20min, 25min, 30min).
Sweat Rate (SR) [Visit #3 (Day 7)]
Sweat rate will be determined based on the difference between pre-and post-weight changes for each bout of exercise, the amount of fluid consumed during the recovery period, and total exercise time in minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 59 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men between the ages of 35 and 59 years
Free of any physical limitations as determined by the Exercise Preparticipation Health Screening Questionnaire for Exercise Professionals (PHSQEP), and a Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
Regularly engaged in endurance exercise (running, cycling, swimming) for a minimum of three years, a weekly training volume of 5-10 hours, and a maximal oxygen uptake of 45.00 ml·kg-1·min-1 or higher as determined by completion of VO2peak assessment (Visit #1).