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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03918395
Other study ID # 171206/B/09
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 21, 2019

Study information

Verified date March 2020
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic resistance training has been shown to increase muscle cross-sectional area, volume and strength. Individuals participating in a resistance training program may wish to consume protein supplements to aid recovery and maximise adaptation. Furthermore, antioxidants have been shown to aid recovery from acute bouts of exercise. However, the effect of antioxidants combined with protein on long term-training adaptation is not fully understood.

This study will combine measures of muscle size, muscle strength and function, and the underlying changes in muscle metabolism in order to assess the effect of consuming a combined protein-antioxidant supplement during a 30 session resistance training program.


Description:

Supplemental protein ingestion is an established method for augmenting gains in fat free mass, muscle strength and muscle cross sectional area following a period of resistance exercise training. In addition to protein, supplements high in polyphenols such as berry and pomegranate extract are believed to be an effective method of reducing soreness and facilitating recovery following a single bout of resistance exercise.

However, whilst polyphenols are shown to facilitate recovery from a single session of resistance exercise, their effect on adaptations to repeated bouts of resistance exercise are unknown. Asking this question will allow a detailed investigation of the mechanisms by which protein-polyphenol ingestion may affect adaptations to resistance exercise training when compared to a non protein or polyphenol containing placebo, which is an important yet underexplored area


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 21, 2019
Est. primary completion date December 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Male and Female

- 18 - 40 years of age

- Recreationally active

Exclusion Criteria:

- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes). Such impairments can affect skeletal muscle metabolism

- Any diagnosed cardiovascular disease or hypertension

- Use of nutritional supplements (e.g. protein, polyphenols, vitamins, antioxidants) as use of nutritional supplements during the study period may interfere with the physiological responses to the supplements of interest administered in this study.

- Habitual dietary protein intake <0.8 g/kg/day or >1.6 g/kg/day as calculated with a three day diet diary. Habitually low protein may impair adaptations to resistance exercise training and a habitually excessive protein intake may negate the benefit of protein supplementation.

- Current musculoskeletal injury that may impair exercise performance or may be exacerbated due to this studies exercise protocol.

- Resistance trained (participating in structured resistance exercise 3 or more times per week for >6 months), endurance trained (participating in structured endurance exercise for >6h per week for >6 months), or sedentary participants as these are not the populations of interest.

- Chronic use of anti-inflammatory medicines prior to the study and unwillingness to refrain from taking anti-inflammatory medications during the study as these medications may affect skeletal muscle metabolism and/or adaptation to exercise.

- Individuals who carry an epi-pen, or those with a diagnosed allergy or who believe that they have an allergy to milk or milk products, crustacean shellfish, tree nuts, or peanuts

- Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients

- Individuals with non removable metallic implants (including heart pacemaker, cochlea implants, medication pumps, surgical clips, plates or screws) or claustrophobia

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo beverage
A placebo beverage will be consumed both post-exercise and pre-bed
Protein-polyphenol beverage
A protein-polyphenol beverage will be consumed both post-exercise and pre-bed

Locations

Country Name City State
United Kingdom University of Exeter Exeter Devon

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cross-sectional area of quadriceps muscle group The cross-sectional area of the muscles comprising the thigh after 30 training sessions will be compared to pre-training values. This will be measured using MRI. After 30 training sessions (approx. 10 weeks)
Secondary Change in quadriceps muscle group volume The volume of the muscles comprising the thigh after 30 training sessions will be compared to pre-training values. This will be measured using MRI. After 30 training sessions (approx. 10 weeks)
Secondary Change in knee extensor isokinetic total work Bilateral knee extensor isokinetic total work will be assessed before and after the training program by quantifying work completed over 30 isokinetic quadriceps contractions on an isokinetic dynamometer. After 30 training sessions (approx. 10 weeks)
Secondary Change in maximal isometric peak torque Knee extensor isometric peak torque will be assessed before and after the training program using an isokinetic dynamometer. After 30 training sessions (approx. 10 weeks)
Secondary Change in maximal isokinetic peak torque Knee extensor isokinetic peak torque over 3 repetitions will be assessed before and after the training program using an isokinetic dynamometer. After 30 training sessions (approx. 10 weeks)
Secondary Change in muscle protein synthesis assessed using the stable isotope Deuterium Oxide The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change over 48 hours will be measured pre- and post-training to calculate a fractional synthesis rate (% day). After 30 training sessions (approx. 10 weeks)
Secondary Perceived quadriceps muscle soreness: Soreness will be assessed at the start of each training session using a validated visual analogue scale (VAS) After 30 training sessions (approx. 10 weeks)
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