Clinical trial NCT06402890: Resistance Training and Hydrolyzed Collagen Supplementation in Middle-aged Adults
Official title: The Effect of Vitamin C-enriched Collagen Combined With Resistance Training on Muscle-tendon Unit Properties in Middle-aged Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet
Food
Nutrition
Keywords: Hydrolyzed collagen
Middle-age
Resistance training
Tendon properties
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this clinical trial is to investigate the longitudinal effects of hydrolyzed collagen ingestion combined with resistance training on muscle-tendon unit structure and function in middle-aged males and females.

The main research questions this clinical trial aims to answer are:

1. Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone in middle-aged health men and women?
2. Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?
3. Does resistance training with hydrolyzed collagen lead to greater increases in strength and power compared to resistance training alone in middle-aged, healthy men and women?

Participants will be randomly assigned to collagen or placebo groups. Participants will perform 24 sessions of high intensity resistance training across 12-weeks. Alongside each training session, participants will consume a beverage containing hydrolyzed collagen or maltodextrin, with both beverages containing vitamin C.

Researchers will compare the collagen and placebo groups to see if there would be beneficial effects on changes in muscle and tendon that are greater than resistance training alone. To achieve this, an dynamometry will be used to assess lower limb strength and ultrasound will be used to measure the morphological, mechanical, and material properties of the patellar tendon, as well the size and architecture of the vastus lateralis muscle.

Detailed description: Healthy, active, middle-aged men and women will ingest a beverage containing 30 g of hydrolyzed collagen with 50 mg of vitamin C or a calorie matched beverage (maltodextrin), also with 50 mg of vitamin C combined with high-volume, high-intensity resistance training for the lower body on 2 - 3 occasions per week for 8-12 weeks.

The aim of this study was to investigate the effect of combining hydrolyzed collagen with resistance training in middle-aged men and women.If supplementation with hydrolyzed collagen leads to a greater change in tendon size, stiffness, and Young's modulus than resistance training alone, this will allow us to recommend this type of intervention to young athletes seeking to improve tendon health and/or athletic performance. This is the first study to investigate the combination of hydrolyzed collage supplementation with resistance training in middle-aged men and women. If supplementation with hydrolyzed leads to greater improvements in tendon size, stiffness, strength and/or power, this will allow us to recommend this type of intervention to middle-aged athletes/trainees seeking to improve tendon health, reduce injury risk, or enhance athletic performance.

The experimental design of both arms will be the same, however Arm 1 will be health, middle-aged male participants and Arm 2 will be health, middle-aged female participants.

Eligibility criteria: Inclusion Criteria:

* Recreationally active or competing in Masters sport
* No history of patellar tendon injuries in the past 6 months
* No history of lower limb musculoskeletal injuries in the past 6 months
* Non-smokers (including e-cigarettes)
* Free from cardiovascular and metabolic diseases

Exclusion Criteria:

* Age \< 35 years or \> 59 years
* Being vegan or vegetarian (due to the mammalian source of collagen)
* Injury history incompatible with lower body resistance training
* Consumption of nutritional supplementation that purportedly affects muscle-tendon adaptation or recovery (i.e. protein powder, vitamin C, collagen)
* BMI over 30 kg/m2

Primary outcomes:
measure: m. vastus lateralis thickness (in millimetres)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: m. vastus lateralis fascicle pennation angle (in degrees)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Patellar tendon cross sectional area (in squared millimetres) at 3 regions along the tendon length
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Patellar tendon stiffness (in Newtons per millimetre)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Bilateral vertical countermovement jump height (in centimetres)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Knee extensor maximal isometric torque (in Newton metres)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Knee extensor rate of torque development (in Newton metres per second)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Barbell back squat 10-repetition maximum (in kilograms)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Bilateral horizontal broad jump distance (in centimetres)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Lower limb maximal isometric force (in Newtons)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: Lower limb isometric rate of force development (in Newtons per second)
timeFrame: 8-12 weeks' training and nutrition intervention
measure: 20-metre sprint time (in seconds)
timeFrame: 8-12 weeks' training and nutrition intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Dr Rob Erskine
Study officials:
affiliation: Liverpool John Moores University
name: Robert M Erskine, PhD
role: STUDY_DIRECTOR
affiliation: Liverpool John Moores University
name: Christopher D Nulty, MSc
role: PRINCIPAL_INVESTIGATOR
References: