SupplementNCT07773142
Skeletal Muscle Adaptations to Peptide-Supplemented Resistance Exercise Training
A study testing Resistance Exercise Training with or without daily supplementation, Dual Energy X-Ray Absorptiometry (DEXA) Scan and Muscle Sampling in people with Supplement and Resistance Training Adaptation, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Skeletal muscle size, an important metabolic tissue, is governed by the balance between two opposing processes, muscle protein synthesis and muscle protein breakdown. In response to long-term resistance exercise (weightlifting), skeletal muscle growth is commonly observed and it is believed that this is due to… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Supplement, Resistance Training Adaptation
- What is being tested?
- Resistance Exercise Training with or without daily supplementation, Dual Energy X-Ray Absorptiometry (DEXA) Scan and Muscle Sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35 years
- Body Mass Index (BMI, calculated by research team based on height and weight) between 18.5-27.4 kg.m-2
- Meeting UK physical activity guidelines (150 mins moderate or 75 mins vigorous activity/week)
- Not currently participating in structured progressive resistance exercise training or have regularly participated in previous 6 months
- In good health, being free from disease or conditions (e.g., Type-II diabetes, hyper/hypothyroidism, irritable bowel syndrome, polycystic ovary syndrome) which influence skeletal muscle metabolism or digestion (self-declared)
Who cannot join
- Have an allergy to ingredients of the supplement or placebo supplement (e.g., legume/bean, corn allergies)
- Have used dietary supplements which are known to affect skeletal muscle recovery and exercise adaptations (e.g., creatine) within the previous month
- Are a smoker/vaper or have a history of smoking/vaping in previous year
- Have a respiratory condition (e.g., asthma, chronic obstructive pulmonary disease)
- Using hormone therapy (not including birth control), anabolic steroids, or recreational drugs
- Are pregnant or currently breastfeeding
Show all 9Show fewer
- Are currently trying to conceive a child
- Have any injury or body weakness which prevents participation in full body resistance exercise
- Have a known allergy to lidocaine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham, Birmingham, B15 2TT
Nathan Hodson, PhD, 07526146514, n.w.hodson@bham.ac.uk
n.w.hodson@bham.ac.uk
About this study
Official title: The Effects of an Innovative Novel Bioactive Peptide Supplement on Skeletal Muscle Anabolism, Autophagy, and Adaptations to Long Term Full Body Resistance Exercise Training in Young Healthy Individuals
Skeletal muscle size, an important metabolic tissue, is governed by the balance between two opposing processes, muscle protein synthesis and muscle protein breakdown. In response to long-term resistance exercise (weightlifting), skeletal muscle growth is commonly observed and it is believed that this is due to increases in muscle protein synthesis which leads to a positive net protein balance stimulating muscle growth. Due to its links to overall metabolic health, maximising muscle growth in response to resistance exercise training has become a significant focus in recent times, with various dietary supplements proposed due to their additive effects on muscle growth with resistance training. Protein supplementation, most commonly whey protein, is the most popular dietary supplement utilised by individuals completing resistance exercise training, however, more recent research has suggested that specific components of whey protein, as well as other foodstuffs, have the potential to individually activate growth pathways within skeletal muscle.
This study will investigate whether daily supplementation with a combination of these compounds is able to produce greater muscle growth, compared to a placebo, when combined with resistance exercise training. We will also investigate whether this supplement can also produce greater increase in strength as well as studying the potential mechanisms behind any of these preferential adaptations in muscle samples which will be collected before and after the training period.
Read the detailed description
Skeletal muscle plays an important role in maintaining human health and well-being, allowing movement and exercise, blood sugar regulation, providing protection from falls, and facilitating tasks of daily living. Strengthening the musculoskeletal system through chronic resistance exercise training can extend both life span and quality of life. Significant research has been dedicated to understanding the anabolic processes which facilitate muscle growth and strength gains during chronic resistance exercise training. It is well known that dietary protein supplementation can enhance the amount of muscle strength and size that is gained by healthy adults across ≥6 weeks of resistance training. These effects are attributed to the increased availability of amino acids which stimulate and support resistance exercise-induced muscle growth. The amino acid leucine plays a key role in initiating the growth of muscle proteins and is abundantly found within animal-based proteins. In recent years, there has been an increase in other commercially available dietary supplements with purported anabolic effects. These include the leucine metabolite β-hydroxy-β-methylbutyrate (HMB), the peptide dileucine comprising two chemically bonded leucine molecules, and peptides found to be abundant in the Fava (Broad) bean (PeptiStrong®). However, whilst there is some evidence which suggests that these supplements can enhance skeletal muscle protein synthesis when consumed in isolation, the combined impact of consuming these compounds on long term muscle growth and resistance training adaptation in young healthy individuals remains to be investigated.
Previous studies have shown that consuming Dileucine or PeptiStrong® can further stimulate the acute muscle protein synthesis response compared to more traditional supplements such as Leucine and whey protein. In addition, HMB supplementation in older males has been shown to promote thigh-lean mass gain during lower-limb resistance training. The impact of these supplements on post-resistance exercise muscle synthesis rates in younger individuals have yet to be evaluated, although, it is possible that a combined dietary supplement could enhance post-exercise muscle anabolism which, over a period of repeated resistance exercise bouts, may induce greater skeletal muscle mass and strength gains. In addition, whether supplementation with these compounds is able to regulate cellular processes which underpin changes in both muscle protein synthesis and breakdown has also not been established.
This project primarily aims to determine whether an innovative bioactive peptide supplement can enhance skeletal muscle adaptations to 8-weeks of resistance training in healthy, young, untrained individuals when compared to a placebo. In addition, this study aims to investigate whether long term resistance exercise training alters human skeletal muscle autophagic flux by utilising a novel ex-vivo autophagic flux assay.
- Conditions
- Supplement, Resistance Training Adaptation
- Being tested
- Resistance Exercise Training with or without daily supplementation, Dual Energy X-Ray Absorptiometry (DEXA) Scan, Muscle Sampling, Blood Sampling, Leg Extensor MVC Test
- Keywords
- skeletal muscle, hypertrophy, autophagy, resistance exercise, resistance training, supplementation
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise Training with or without daily supplementationOther
The intervention involves undertaking 3 supervised, in person, training sessions per week for 8 weeks, which are designed to increase muscle mass and strength of all major muscle groups. Each session will involve performing 7 different exercises in the order of a seated chest press, standing overhead press, bent-over row, 45-degree leg press, knee extension, seated hamstring curl, and a seated calf press. For each exercise, participants perform 4 working sets to volitional failure with 75% 1RM with a two-minute rest period will be given between sets. Resistance exercise loads will be adjusted between sets to ensure that participants consistently reach volitional failure between 8-12 repetitions and reset during week 5 when interim 1RM tests are undertaken. Throughout this period, participant will consume their assigned supplement daily either in the morning on non-training days or within 30 mins of training on training days.
Dual Energy X-Ray Absorptiometry (DEXA) ScanRadiation
Participant's body composition will be determined through a full body DEXA scan before and after the intervention. They will have their height and weight determined prior to this scan to confirm their BMI and to calibrate the DEXA machine. The DEXA scan involves resting supine for approximately 20 minutes whilst the machine utilises a low dose of ionising radiation to estimate the total amount of fat mass and fat-free (lean) mass. The distribution of these is also determined across different body segments. The dosage of radiation is approximately 10 micro-Sieverts (µSv), which is far lower than the 80µSv airline passengers are typically exposed to during a single transatlantic flight. Scans will be conducted in line with IRMER regulations/guidelines by an appropriately trained individual.
Muscle SamplingProcedure or surgery
Before and after the 8-week training intervention, a skeletal muscle (vastus lateralis) biopsy sample will be obtained from participants. This will be completed by a trained individual, in sterile conditions and under local anaesthetic using the Bergstrom needle technique modified for suction. These will be immediately processed and stored for subsequent analysis following intervention completion by all participants.
Blood SamplingProcedure or surgery
Before and after the 8 week training intervention, a single 10ml venous blood sample will be collected from participant's antecubital vein. Serum and plasma will be subsequently isolated from the sample and stored for future analysis.
Leg Extensor MVC TestOther
This uses an isokinetic dynamometer to determine the peak amount of force that the leg extensor (thigh) muscles can produce during a voluntary muscle contraction. Participants will be required to sit on a padded dynameter chair with their lower legs naturally hanging over the edge of the chair, bent at a 90-degree angle. On each attempt, participants will be asked to cross their arms over their upper body and, following a count of 3 seconds, to kick as hard and as fast as possible into the stationary shin pad for 5 seconds, with peak force recorded during each attempt. This will be completed before and after the 8 week training/supplement intervention.
1 repetition maximum testsOther
Participants will next complete 1RM strength tests for 7 different resistance exercises before, mid-way and after the intervention. Each exercise will target different areas of the body and will be performed throughout the 8-week training programme. These include a seated chest press, standing overhead press, bent-over row, 45-degree leg press, knee extension, seated hamstring curl, and seated calf press. This involves lifting progressively increasing loads for each exercise until a single repetition can no longer be completed with correct form. Attempts will be separated by a rest interval of 2 minutes.
Ultrasound VL Muscle Thickness/Cross-sectional Area MeasurementProcedure or surgery
Participants will have their vastus lateralis muscle thickness and cross-sectional area measured via an Ultrasound scan. They will be asked to lie still on a medical examination couch whilst a member of the research team locates the position of their greater trochanter and lateral condyle of the femur. The ultrasound probe will then be placed on this mark and repositioned vertically to identify the medial and lateral borders of the VL. The midpoint of these locations will be marked and the distance between the superficial and deep aponeuroses of the VL muscle will be measured to quantify VL muscle thickness. A wide-view image spanning the entire cross-section of the vastus lateralis will also be obtained for cross-sectional area assessment.
3-day weighed food diaryOther
Participants will be asked to record a 3-day weighted food diary on weeks 1, 5 and 8 of the resistance training programme. The choice of days will be at the participants discretion but must include 2 weekdays and 1 weekend day to account for dietary variation throughout the week. On these days, they will be required to record all food and drink consumed which contains calories, including the weight/volume and branding. Food diaries will be analysed for macronutrient and caloric intake. This data will be used to determine whether participant's diets, especially protein intake, remains relatively stable throughout the interventional period. Full instructions on how to properly record a weighted food diary will be provided by the research team at the start of the training period. Depending on participant preference, diaries may be recorded physically within a provided logbook or electronically using a mobile application (MyFitnessPal). Weighing scales will be provided by the research team
Daily Supplementation with active or placebo comparatorDietary supplement
In a double-blind manner, participants will be randomised to supplement or placebo cohorts. Assigned supplements will be consumed daily across the 8-week intervention either in the morning on non-training days or with 30 minutes of training on training days. The placebo will contain maltodextrin carbohydrate, whereas the supplement will comprise 5 active ingredients: 1) Dileucine (Peptide 185™, 2g/serving), 2) PeptiStrong®( 2.4g/serving), a trademarked hydrolysed Broad Bean (Vicia faba) protein extract, 3) Calcium β-hydroxy-β-methylbutyrate monohydrate (myHMB®, 1.5g/serving), a leucine metabolite in its calcium salt form, 4) Creatine monohydrate (5g/serving), , and 5) PepForm® creatine monohydrate (1g/serving), a trademarked creatine monohydrate product where creatine is bound to peptides derived from whey proteins. Supplements will be provided in opaque contained withs instructions to add one scoop (provided) of supplement/placebo to 300ml water.
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Active comparator | The supplement will comprise 5 active ingredients: 1) Dileucine (Peptide 185™, 2g/serving), comprising two chemically bonded leucine amino acid molecules which are commonly found within animal protein sources, 2) PeptiStrong®( 2.4g/serving), a trademarked hydrolysed Broad Bean (Vicia faba) protein extract, 3) Calcium β-hydroxy-β-methylbutyrate monohydrate (myHMB®, 1.5g/serving), a leucine metabolite in its calcium salt form, 4) Creatine monohydrate (5g/serving), a well-researched dietary supplement which increases muscle strength and power by improving cellular energy availability, and 5) PepForm® creatine monohydrate (1g/serving), a trademarked creatine monohydrate product which is purported to enhance creatine bioavailability by binding creatine with peptides derived from whey protein.
The supplement will be consumed daily throughout the 8-week training period - in the morning on non-training days and within 30 minutes of completing training session on training days. Receives: Other: Resistance Exercise Training with or without daily supplementation; Radiation: Dual Energy X-Ray Absorptiometry (DEXA) Scan; Procedure: Muscle Sampling; Procedure: Blood Sampling; Other: Leg Extensor MVC Test; Other: 1 repetition maximum tests; Procedure: Ultrasound VL Muscle Thickness/Cross-sectional Area Measurement; Other: 3-day weighed food diary; Dietary Supplement: Daily Supplementation with active or placebo comparator |
| Placebo | Placebo comparator | The placebo will contain 12g maltodextrin per serving and is taste and colour matched to the active comparator. The placebo will be consumed daily throughout the 8-week training period - in the morning on non-training days and within 30 minutes of completing training session on training days. Receives: Other: Resistance Exercise Training with or without daily supplementation; Radiation: Dual Energy X-Ray Absorptiometry (DEXA) Scan; Procedure: Muscle Sampling; Procedure: Blood Sampling; Other: Leg Extensor MVC Test; Other: 1 repetition maximum tests; Procedure: Ultrasound VL Muscle Thickness/Cross-sectional Area Measurement; Other: 3-day weighed food diary; Dietary Supplement: Daily Supplementation with active or placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Press 1RM strength
Maximal strength completed on a 45 degree incline, weight plate-loaded leg press machine (statistically powered primary outcome)
Measured: From enrolment to the final testing visit of the participant (~5 days following final testing session)
1RM strength for seated chest press, standing overhead press, bent-over row, 45-degree leg press, knee extension, seated hamstring curl, and standing calf press
Maximal Strength on all other exercises completed in training sessions throughout intervention
Measured: From enrolment to the final testing visit of the participant (~5 days following final testing session)
Leg extensor MVC
Maximal force production in a isometric knee extension movement using a dynamometer
Measured: From enrolment to the final testing visit of the participant (~5 days following final testing session)
Muscle growth/hypertrophy
Assessments of muscle growth/hypertrophy through macro- and micro-scopic assessments:
- B-mode ultrasound assessments of vastus lateralis cross-sectional area and thickness
- Immunofluorescence microscopy to assess fibre-type specific changes in fibre cross-sectional area
Measured: From enrolment to the final testing visit of the participant (~5 days following final testing session) for ultrasound assessments. Muscle samples will be analysed for fibre CSA from end of final participant testing until end of study date.
Secondary outcomes (5)
Body Composition
Assessment of fat mass and fat-free mass derived from Dual energy X-ray Absorptiometry (DEXA) scans
Measured: From enrolment to the final testing visit of the participant (~5 days following final testing session)
Skeletal muscle autophagic flux
Autophagic flux will be assessed in skeletal muscle samples utilising an ex-vivo assay followed by immunoblotting
Measured: Skeletal muscle samples will be analysed from the final participant session until the study end date.
Lysosome and autophagy-related protein content
Assessed via immunoblotting with validated antibodies
Measured: Skeletal muscle samples will be analysed from the final participant session until the study end date.
Autophagic and anabolic signalling processes (phosphorylation events, translocation, colocalization)
Assessed via immunoblotting and/or immunofluorescence with validated antibodies
Measured: Skeletal muscle samples will be analysed from the final participant session until the study end date.
Satellite Cell Content
Assessed via immunofluorescence microscopy staining for PAX7 protein
Measured: Skeletal muscle samples will be analysed from the final participant session until the study end date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start14 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-arm, randomised, double-blind placebo controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Hodson, University of Birmingham
- Investigators
- Nathan Hodson, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773142
- Sponsor's protocol ID
- RG_26-018
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in publications arising from the project will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Innovative Novel Bioactive Peptide Supplement on Skeletal Muscle Anabolism, Autophagy, and Adaptations to Long Term Full Body Resistance Exercise Training in Young Healthy Individuals
- ClinicalTrials.gov ID
- NCT07773142
- Acronym / sponsor ID
- RG_26-018
- Conditions
- Supplement, Resistance Training Adaptation
- Keywords
- skeletal muscle, hypertrophy, autophagy, resistance exercise, resistance training, supplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Skeletal muscle size, an important metabolic tissue, is governed by the balance between two opposing processes, muscle protein synthesis and muscle protein breakdown. In response to long-term resistance exercise (weightlifting), skeletal muscle growth is commonly observed and it is believed that this is due to increases in muscle protein synthesis which leads to a positive net protein balance stimulating muscle growth. Due to its links to overall metabolic health, maximising muscle growth in response to resistance exercise training has become a significant focus in recent times, with various dietary supplements proposed due to their additive effects on muscle growth with resistance training. Protein supplementation, most commonly whey protein, is the most popular dietary supplement utilised by individuals completing resistance exercise training, however, more recent research has suggested that specific components of whey protein, as well as other foodstuffs, have the potential to individually activate growth pathways within skeletal muscle.
This study will investigate whether daily supplementation with a combination of these compounds is able to produce greater muscle growth, compared to a placebo, when combined with resistance exercise training. We will also investigate whether this supplement can also produce greater increase in strength as well as studying the potential mechanisms behind any of these preferential adaptations in muscle samples which will be collected before and after the training period.
Detailed description
Skeletal muscle plays an important role in maintaining human health and well-being, allowing movement and exercise, blood sugar regulation, providing protection from falls, and facilitating tasks of daily living. Strengthening the musculoskeletal system through chronic resistance exercise training can extend both life span and quality of life. Significant research has been dedicated to understanding the anabolic processes which facilitate muscle growth and strength gains during chronic resistance exercise training. It is well known that dietary protein supplementation can enhance the amount of muscle strength and size that is gained by healthy adults across ≥6 weeks of resistance training. These effects are attributed to the increased availability of amino acids which stimulate and support resistance exercise-induced muscle growth. The amino acid leucine plays a key role in initiating the growth of muscle proteins and is abundantly found within animal-based proteins. In recent years, there has been an increase in other commercially available dietary supplements with purported anabolic effects. These include the leucine metabolite β-hydroxy-β-methylbutyrate (HMB), the peptide dileucine comprising two chemically bonded leucine molecules, and peptides found to be abundant in the Fava (Broad) bean (PeptiStrong®). However, whilst there is some evidence which suggests that these supplements can enhance skeletal muscle protein synthesis when consumed in isolation, the combined impact of consuming these compounds on long term muscle growth and resistance training adaptation in young healthy individuals remains to be investigated.
Previous studies have shown that consuming Dileucine or PeptiStrong® can further stimulate the acute muscle protein synthesis response compared to more traditional supplements such as Leucine and whey protein. In addition, HMB supplementation in older males has been shown to promote thigh-lean mass gain during lower-limb resistance training. The impact of these supplements on post-resistance exercise muscle synthesis rates in younger individuals have yet to be evaluated, although, it is possible that a combined dietary supplement could enhance post-exercise muscle anabolism which, over a period of repeated resistance exercise bouts, may induce greater skeletal muscle mass and strength gains. In addition, whether supplementation with these compounds is able to regulate cellular processes which underpin changes in both muscle protein synthesis and breakdown has also not been established.
This project primarily aims to determine whether an innovative bioactive peptide supplement can enhance skeletal muscle adaptations to 8-weeks of resistance training in healthy, young, untrained individuals when compared to a placebo. In addition, this study aims to investigate whether long term resistance exercise training alters human skeletal muscle autophagic flux by utilising a novel ex-vivo autophagic flux assay.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-arm, randomised, double-blind placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Supplement | Active comparator | Other: Resistance Exercise Training with or without daily supplementation, Radiation: Dual Energy X-Ray Absorptiometry (DEXA) Scan, Procedure: Muscle Sampling, Procedure: Blood Sampling, Other: Leg Extensor MVC Test, Other: 1 repetition maximum tests, Procedure: Ultrasound VL Muscle Thickness/Cross-sectional Area Measurement, Other: 3-day weighed food diary, Dietary Supplement: Daily Supplementation with active or placebo comparatorThe supplement will comprise 5 active ingredients: 1) Dileucine (Peptide 185™, 2g/serving), comprising two chemically bonded leucine amino acid molecules which are commonly found within animal protein sources, 2) PeptiStrong®( 2.4g/serving), a trademarked hydrolysed Broad Bean (Vicia faba) protein extract, 3) Calcium β-hydroxy-β-methylbutyrate monohydrate (myHMB®, 1.5g/serving), a leucine metabolite in its calcium salt form, 4) Creatine monohydrate (5g/serving), a well-researched dietary supplement which increases muscle strength and power by improving cellular energy availability, and 5) PepForm® creatine monohydrate (1g/serving), a trademarked creatine monohydrate product which is purported to enhance creatine bioavailability by binding creatine with peptides derived from whey protein. The supplement will be consumed daily throughout the 8-week training period - in the morning on non-training days and within 30 minutes of completing training session on training days. |
| Placebo | Placebo comparator | Other: Resistance Exercise Training with or without daily supplementation, Radiation: Dual Energy X-Ray Absorptiometry (DEXA) Scan, Procedure: Muscle Sampling, Procedure: Blood Sampling, Other: Leg Extensor MVC Test, Other: 1 repetition maximum tests, Procedure: Ultrasound VL Muscle Thickness/Cross-sectional Area Measurement, Other: 3-day weighed food diary, Dietary Supplement: Daily Supplementation with active or placebo comparatorThe placebo will contain 12g maltodextrin per serving and is taste and colour matched to the active comparator. The placebo will be consumed daily throughout the 8-week training period - in the morning on non-training days and within 30 minutes of completing training session on training days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-35 years
- Body Mass Index (BMI, calculated by research team based on height and weight) between 18.5-27.4 kg.m-2
- Meeting UK physical activity guidelines (150 mins moderate or 75 mins vigorous activity/week)
- Not currently participating in structured progressive resistance exercise training or have regularly participated in previous 6 months
- In good health, being free from disease or conditions (e.g., Type-II diabetes, hyper/hypothyroidism, irritable bowel syndrome, polycystic ovary syndrome) which influence skeletal muscle metabolism or digestion (self-declared)
Key exclusion criteria (9 listed)
- Have an allergy to ingredients of the supplement or placebo supplement (e.g., legume/bean, corn allergies)
- Have used dietary supplements which are known to affect skeletal muscle recovery and exercise adaptations (e.g., creatine) within the previous month
- Are a smoker/vaper or have a history of smoking/vaping in previous year
- Have a respiratory condition (e.g., asthma, chronic obstructive pulmonary disease)
- Using hormone therapy (not including birth control), anabolic steroids, or recreational drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise Training with or without daily supplementationThe intervention involves undertaking 3 supervised, in person, training sessions per week for 8 weeks, which are designed to increase muscle mass and strength of all major muscle groups. Each session will involve performing 7 different exercises in the order of a seated chest press, standing overhead press, bent-over row, 45-degree leg press, knee extension, seated hamstring curl, and a seated calf press. For each exercise, participants perform 4 working sets to volitional failure with 75% 1RM with a two-minute rest period will be given between sets. Resistance exercise loads will be adjusted between sets to ensure that participants consistently reach volitional failure between 8-12 repetitions and reset during week 5 when interim 1RM tests are undertaken. Throughout this period, participant will consume their assigned supplement daily either in the morning on non-training days or within 30 mins of training on training days. | Other | Placebo, Supplement |
| Dual Energy X-Ray Absorptiometry (DEXA) ScanParticipant's body composition will be determined through a full body DEXA scan before and after the intervention. They will have their height and weight determined prior to this scan to confirm their BMI and to calibrate the DEXA machine. The DEXA scan involves resting supine for approximately 20 minutes whilst the machine utilises a low dose of ionising radiation to estimate the total amount of fat mass and fat-free (lean) mass. The distribution of these is also determined across different body segments. The dosage of radiation is approximately 10 micro-Sieverts (µSv), which is far lower than the 80µSv airline passengers are typically exposed to during a single transatlantic flight. Scans will be conducted in line with IRMER regulations/guidelines by an appropriately trained individual. | Radiation | Placebo, Supplement |
| Muscle SamplingBefore and after the 8-week training intervention, a skeletal muscle (vastus lateralis) biopsy sample will be obtained from participants. This will be completed by a trained individual, in sterile conditions and under local anaesthetic using the Bergstrom needle technique modified for suction. These will be immediately processed and stored for subsequent analysis following intervention completion by all participants. | Procedure or surgery | Placebo, Supplement |
| Blood SamplingBefore and after the 8 week training intervention, a single 10ml venous blood sample will be collected from participant's antecubital vein. Serum and plasma will be subsequently isolated from the sample and stored for future analysis. | Procedure or surgery | Placebo, Supplement |
| Leg Extensor MVC TestThis uses an isokinetic dynamometer to determine the peak amount of force that the leg extensor (thigh) muscles can produce during a voluntary muscle contraction. Participants will be required to sit on a padded dynameter chair with their lower legs naturally hanging over the edge of the chair, bent at a 90-degree angle. On each attempt, participants will be asked to cross their arms over their upper body and, following a count of 3 seconds, to kick as hard and as fast as possible into the stationary shin pad for 5 seconds, with peak force recorded during each attempt. This will be completed before and after the 8 week training/supplement intervention. | Other | Placebo, Supplement |
| 1 repetition maximum testsParticipants will next complete 1RM strength tests for 7 different resistance exercises before, mid-way and after the intervention. Each exercise will target different areas of the body and will be performed throughout the 8-week training programme. These include a seated chest press, standing overhead press, bent-over row, 45-degree leg press, knee extension, seated hamstring curl, and seated calf press. This involves lifting progressively increasing loads for each exercise until a single repetition can no longer be completed with correct form. Attempts will be separated by a rest interval of 2 minutes. | Other | Placebo, Supplement |
| Ultrasound VL Muscle Thickness/Cross-sectional Area MeasurementParticipants will have their vastus lateralis muscle thickness and cross-sectional area measured via an Ultrasound scan. They will be asked to lie still on a medical examination couch whilst a member of the research team locates the position of their greater trochanter and lateral condyle of the femur. The ultrasound probe will then be placed on this mark and repositioned vertically to identify the medial and lateral borders of the VL. The midpoint of these locations will be marked and the distance between the superficial and deep aponeuroses of the VL muscle will be measured to quantify VL muscle thickness. A wide-view image spanning the entire cross-section of the vastus lateralis will also be obtained for cross-sectional area assessment. | Procedure or surgery | Placebo, Supplement |
| 3-day weighed food diaryParticipants will be asked to record a 3-day weighted food diary on weeks 1, 5 and 8 of the resistance training programme. The choice of days will be at the participants discretion but must include 2 weekdays and 1 weekend day to account for dietary variation throughout the week. On these days, they will be required to record all food and drink consumed which contains calories, including the weight/volume and branding. Food diaries will be analysed for macronutrient and caloric intake. This data will be used to determine whether participant's diets, especially protein intake, remains relatively stable throughout the interventional period. Full instructions on how to properly record a weighted food diary will be provided by the research team at the start of the training period. Depending on participant preference, diaries may be recorded physically within a provided logbook or electronically using a mobile application (MyFitnessPal). Weighing scales will be provided by the research team | Other | Placebo, Supplement |
| Daily Supplementation with active or placebo comparatorIn a double-blind manner, participants will be randomised to supplement or placebo cohorts. Assigned supplements will be consumed daily across the 8-week intervention either in the morning on non-training days or with 30 minutes of training on training days. The placebo will contain maltodextrin carbohydrate, whereas the supplement will comprise 5 active ingredients: 1) Dileucine (Peptide 185™, 2g/serving), 2) PeptiStrong®( 2.4g/serving), a trademarked hydrolysed Broad Bean (Vicia faba) protein extract, 3) Calcium β-hydroxy-β-methylbutyrate monohydrate (myHMB®, 1.5g/serving), a leucine metabolite in its calcium salt form, 4) Creatine monohydrate (5g/serving), , and 5) PepForm® creatine monohydrate (1g/serving), a trademarked creatine monohydrate product where creatine is bound to peptides derived from whey proteins. Supplements will be provided in opaque contained withs instructions to add one scoop (provided) of supplement/placebo to 300ml water. | Dietary supplement | Placebo, Supplement |
Primary outcome
Leg Press 1RM strength
Time frame: From enrolment to the final testing visit of the participant (~5 days following final testing session)
Maximal strength completed on a 45 degree incline, weight plate-loaded leg press machine (statistically powered primary outcome)
1RM strength for seated chest press, standing overhead press, bent-over row, 45-degree leg press, knee extension, seated hamstring curl, and standing calf press
Time frame: From enrolment to the final testing visit of the participant (~5 days following final testing session)
Maximal Strength on all other exercises completed in training sessions throughout intervention
Leg extensor MVC
Time frame: From enrolment to the final testing visit of the participant (~5 days following final testing session)
Maximal force production in a isometric knee extension movement using a dynamometer
Muscle growth/hypertrophy
Time frame: From enrolment to the final testing visit of the participant (~5 days following final testing session) for ultrasound assessments. Muscle samples will be analysed for fibre CSA from end of final participant testing until end of study date.
Assessments of muscle growth/hypertrophy through macro- and micro-scopic assessments: * B-mode ultrasound assessments of vastus lateralis cross-sectional area and thickness * Immunofluorescence microscopy to assess fibre-type specific changes in fibre cross-sectional area
5 secondary outcomes
Body Composition
Time frame: From enrolment to the final testing visit of the participant (~5 days following final testing session)
Skeletal muscle autophagic flux
Time frame: Skeletal muscle samples will be analysed from the final participant session until the study end date.
Lysosome and autophagy-related protein content
Time frame: Skeletal muscle samples will be analysed from the final participant session until the study end date.
Autophagic and anabolic signalling processes (phosphorylation events, translocation, colocalization)
Time frame: Skeletal muscle samples will be analysed from the final participant session until the study end date.
Satellite Cell Content
Time frame: Skeletal muscle samples will be analysed from the final participant session until the study end date.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD used in publications arising from the project will be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Hodson principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Training with or without daily supplementation, Dual Energy X-Ray Absorptiometry (DEXA) Scan and Muscle Sampling in people with Supplement and Resistance Training Adaptation, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Hodson, PhD (07526146514, n.w.hodson@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg Press 1RM strength (time frame: From enrolment to the final testing visit of the participant (~5 days following final testing session)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.