Healthy AgingNCT07858292
Vicia Faba Peptides and Resistance Training in the Elderly
A study testing Vicia faba L.-derived peptides and Supervised Resistance Training in people with Healthy Aging, run by Universidade Cesumar (UNICESUMAR) at 1 site in Brazil.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of supplementation with peptides derived from Vicia faba L. combined with supervised resistance training in physically active and inactive older adults. Approximately 100 adults aged 60 years or older will be enrolled. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Vicia faba L.-derived peptides and Supervised Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2026to Jan 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years or older;
- Classification as physically active or physically inactive according to the criteria established in the study;
- Clinical and functional conditions compatible with participation in the assessments and resistance training program;
- Availability to participate in the activities scheduled throughout the intervention period;
- Provision of written informed consent.
Who cannot join
- Musculoskeletal injuries or conditions that prevent or compromise the safe performance of physical assessments or resistance training;
- Acute or uncontrolled clinical or psychiatric conditions that may compromise participant safety or adherence to the study protocol;
- Neurodegenerative diseases associated with relevant functional or cognitive impairment;
- Use of restrictive diets that may interfere with dietary intake or body composition outcomes;
- Use of medications specifically intended for weight loss;
- Regular use of ergogenic supplements with the potential to interfere with the muscular or metabolic adaptations investigated in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
UniCesumar - Centro Universitário Cesumar
Maringá, Paraná, 87050-900
About this study
Official title: Investigation of the (Potential) Therapeutic Effects of Vicia Faba L. Peptides Combined With Resistance Training on the Strength, Function, and Body Composition of Physically Active and Inactive Older Adults: A Randomized, Double-Blind, Placebo-Controlled Clinical Study
This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of supplementation with peptides derived from Vicia faba L. combined with supervised resistance training in physically active and inactive older adults.
Approximately 100 adults aged 60 years or older will be enrolled. Participants will first be classified as physically active or inactive according to their habitual physical activity level and will then be randomly assigned to receive either Vicia faba L.-derived peptides (2.5 g/day) or placebo. All participants will complete the same supervised resistance training program three times per week for four weeks and will receive nutritional monitoring.
Assessments will be performed before and after the intervention to investigate changes in muscle strength and power, body composition, functional mobility, postural balance, physical function, frailty, mental health, quality of life, and cognitive performance. The study will also examine whether habitual physical activity level influences the responses to the combined supplementation and resistance training intervention.
- Conditions
- Healthy Aging
- Being tested
- Vicia faba L.-derived peptides, Placebo, Supervised Resistance Training
- Keywords
- Aging, Resistance Training, Dietary Supplements, Sarcopenia, Body Composition
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicia faba L.-derived peptidesDietary supplement
Participants assigned to the experimental intervention will receive 2.5 g/day of Vicia faba L.-derived peptides for four weeks. The supplement will be administered once daily as a powder using a measuring scoop containing the prescribed dose and diluted in 300 mL of drinking water. Participants will consume the supplement at home every day, including weekends. Containers will be returned at the end of the intervention to assess adherence.
PlaceboDietary supplement
Participants assigned to the placebo intervention will receive silicified microcrystalline cellulose once daily for four weeks. The placebo will be administered as a powder diluted in 300 mL of drinking water and will be standardized to match the mode of presentation and administration of the experimental supplement. Participants will consume the placebo at home every day, including weekends. Containers will be returned at the end of the intervention to assess adherence.
Supervised Resistance TrainingBehavioural
All participants will complete a supervised resistance training program for four weeks, with three sessions per week performed on non-consecutive days. The program will target the major muscle groups of the upper and lower limbs using resistance-training equipment, free weights, and other available implements. Exercise prescription will be individualized according to each participant's functional capacity, previous experience, and clinical limitations. Training loads will be progressively adjusted throughout the intervention according to individual progress and exercise tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Physically Active + Vicia faba Peptides | Experimental | Physically active older adults randomized to receive 2.5 g/day of Vicia faba L.-derived peptides for four weeks. The supplement will be administered once daily as a powder diluted in 300 mL of water. Participants will also complete the same supervised resistance training program three times per week on non-consecutive days. Receives: Dietary Supplement: Vicia faba L.-derived peptides; Behavioral: Supervised Resistance Training |
| Physically Active + Placebo | Placebo comparator | Physically active older adults randomized to receive a placebo containing silicified microcrystalline cellulose once daily for four weeks. The placebo will be administered as a powder diluted in 300 mL of water and standardized to match the mode of presentation and administration of the experimental supplement. Participants will also complete the same supervised resistance training program three times per week on non-consecutive days. Receives: Dietary Supplement: Placebo; Behavioral: Supervised Resistance Training |
| Physically Inactive + Vicia faba Peptides | Experimental | Physically inactive older adults randomized to receive 2.5 g/day of Vicia faba L.-derived peptides for four weeks. The supplement will be administered once daily as a powder diluted in 300 mL of water. Participants will also complete the same supervised resistance training program three times per week on non-consecutive days. Receives: Dietary Supplement: Vicia faba L.-derived peptides; Behavioral: Supervised Resistance Training |
| Physically Inactive + Placebo | Placebo comparator | Physically inactive older adults randomized to receive a placebo containing silicified microcrystalline cellulose once daily for four weeks. The placebo will be administered as a powder diluted in 300 mL of water and standardized to match the mode of presentation and administration of the experimental supplement. Participants will also complete the same supervised resistance training program three times per week on non-consecutive days. Receives: Dietary Supplement: Placebo; Behavioral: Supervised Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat-Free Mass (kg)
Change in fat-free mass following the 4-week intervention. Fat-free mass will be assessed using multifrequency bioelectrical impedance analysis (InBody 570) under standardized pre-assessment conditions. Fat-free mass will be expressed in kilograms (kg).
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (11)
Change in Handgrip Strength (kgf)
Change in handgrip strength. Handgrip strength will be assessed using a hydraulic hand dynamometer. Three measurements will be performed for each hand, with approximately 30 seconds of rest between attempts. The mean of the three measurements will be used for analysis, and results will be expressed in kilograms-force (kgf).
Measured: Baseline and after 4 weeks of intervention
Change in Maximal Voluntary Isometric Contraction and Muscle Power during Knee Extension and Flexion
Maximal Voluntary Isometric Contraction (MVIC) and Muscle Power during Knee Extension and Flexion will be assessed using a Biodex Multi-Joint System dynamometer. Muscle power during concentric knee flexion and extension will be evaluated at angular velocities of 60°/s and 180°/s. MVIC will be measured across 3 attempts, with a 1-minute resting interval, with the knee flexed at 90°. Outcome for MVIC will include peak torque (N·m), while outcome for muscle power will consist in total work done.
Measured: Baseline and after 4 weeks of intervention
Change in Lower-Limb Strength Endurance (repetitions)
Lower-limb strength endurance will be assessed using the 30-Second Chair Stand Test. The outcome will include the total number of complete sit-to-stand repetitions performed within 30 seconds.
Measured: Baseline and after 4 weeks of intervention
Change in Upper-Limb Muscle Power (meters)
Upper-limb muscle power will be assessed using the Seated Medicine Ball Throw Test. With the bench standing in 45°, participants will throw a medicine ball (3 kg for men, 2 kg for women) forward from a seated position using a chest-pass movement. Throwing distance, in meters, will be measured from the starting point to the point where the ball first contacts the floor.
Measured: Baseline and after 4 weeks of intervention
Change in Dynamic Balance
Dynamic balance will be assessed using the Instrumented Timed Up and Go (iTUG) test with the Baiobit inertial sensor system. Outcomes will include total completion time (in seconds) and kinematic parameters related to the different phases of the task.
Measured: Baseline and after 4 weeks of intervention
Change in Self-Reported Functional Disability
Self-reported functional disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), an instrument developed by the World Health Organization for the cross-sectional measurement of functional disability, applicable to any health condition. Scores will be calculated according to the World Health Organization technical manual using the simple scoring method, in which raw scores for each domain are summed and subsequently transformed into a 0-100 point scale, where higher values indicate a greater level of disability.
Measured: Baseline and after 4 weeks of intervention
Change in body fat percentage
Change in body fat percentage, in percent, will be assessed using multifrequency bioelectrical impedance analysis (InBody 570) under standardized pre-assessment conditions.
Measured: Baseline and after 4 weeks of intervention
Change in Vastus Lateralis and Rectus Femoris Muscle Thickness (cm)
Change in Vastus lateralis and Rectus Femoris Muscle Thickness will be assessed by ultrasonography of the dominant limb at 30 and 70% of the distance from the greater trochanter of the femur and the lateral femoral condyle. Muscle thickness will be measured in centimeters.
Measured: Baseline and after 4 weeks of intervention
Change in Physical Frailty Phenotype
Physical frailty will be assessed using the Fried Frailty Phenotype, which includes five components: unintentional weight loss, self-reported exhaustion, reduced handgrip strength, slow walking speed, and low physical activity level. Participants will be classified as non-frail, pre-frail, or frail.
Measured: Baseline and after 4 weeks of intervention
Change in Intensity of Depressive Symptoms
Change in the intensity of depressive symptoms will be assessed using the Beck Depression Inventory - Second Edition (BDI-II), a self-report instrument widely used to measure the severity of depressive symptoms and validated for the Brazilian population. The questionnaire consists of 21 items, each containing four options graded from 0 to 3 points, reflecting the increasing intensity of symptoms over the past two weeks. The total score ranges from 0 to 63 points, with higher scores indicating greater severity of depressive symptoms. To interpret the results, the following conventionally used cut-off points will be adopted: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe).
Measured: Baseline and after 4 weeks of intervention
Change in Quality of Life
Change in Quality of life will be assessed using the World Health Organization Quality of Life-OLD (WHOQOL-OLD). The instrument consists of 24 questions distributed across six facets: Sensory Functioning, Autonomy, Past/Present/Future Activities, Social Participation, Death and Dying, and Intimacy. Each facet comprises four questions, resulting in a multidimensional assessment of quality of life related to aging. Responses are recorded on a five-point Likert scale (ranging from 1 to 5) based on the degree of intensity, satisfaction, frequency, or agreement associated with each question. Initially, the values obtained for each facet will be summed, followed by the transformation of the scores onto a 0-100 scale, allowing for better interpretation and comparison of results across participants and different assessment time points. On this transformed scale, higher values will indicate a better perception of quality of life.
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will first be stratified according to their habitual physical activity level as physically active or physically inactive. Within each stratum, participants will be randomized in a 1:1 ratio to receive either Vicia faba L.-derived peptide supplementation or placebo. This procedure will result in four parallel study groups: physically active + Vicia faba, physically active + placebo, physically inactive + Vicia faba, and physically inactive + placebo. All groups will undergo the same supervised resistance training program.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cesumar (UNICESUMAR)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vitor S Painelli, Dr, Principal investigator, Centro Universitário Cesumar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858292
- Sponsor's protocol ID
- 01401926.7.0000.5539
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the (Potential) Therapeutic Effects of Vicia Faba L. Peptides Combined With Resistance Training on the Strength, Function, and Body Composition of Physically Active and Inactive Older Adults: A Randomized, Double-Blind, Placebo-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07858292
- Acronym / sponsor ID
- 01401926.7.0000.5539
- Conditions
- Healthy Aging
- Keywords
- Aging, Resistance Training, Dietary Supplements, Sarcopenia, Body Composition
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Universidade Cesumar (UNICESUMAR)University, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Oct 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.
This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of supplementation with peptides derived from Vicia faba L. combined with supervised resistance training in physically active and inactive older adults.
Approximately 100 adults aged 60 years or older will be enrolled. Participants will first be classified as physically active or inactive according to their habitual physical activity level and will then be randomly assigned to receive either Vicia faba L.-derived peptides (2.5 g/day) or placebo. All participants will complete the same supervised resistance training program three times per week for four weeks and will receive nutritional monitoring.
Assessments will be performed before and after the intervention to investigate changes in muscle strength and power, body composition, functional mobility, postural balance, physical function, frailty, mental health, quality of life, and cognitive performance. The study will also examine whether habitual physical activity level influences the responses to the combined supplementation and resistance training intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Participants will first be stratified according to their habitual physical activity level as physically active or physically inactive. Within each stratum, participants will be randomized in a 1:1 ratio to receive either Vicia faba L.-derived peptide supplementation or placebo. This procedure will result in four parallel study groups: physically active + Vicia faba, physically active + placebo, physically inactive + Vicia faba, and physically inactive + placebo. All groups will undergo the same supervised resistance training program.
| Arm | Type | Receives |
|---|---|---|
| Physically Active + Vicia faba Peptides | Experimental | Dietary Supplement: Vicia faba L.-derived peptides, Behavioral: Supervised Resistance TrainingPhysically active older adults randomized to receive 2.5 g/day of Vicia faba L.-derived peptides for four weeks. The supplement will be administered once daily as a powder diluted in 300 mL of water. Participants will also complete the same supervised resistance training program three times per week on non-consecutive days. |
| Physically Active + Placebo | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Supervised Resistance TrainingPhysically active older adults randomized to receive a placebo containing silicified microcrystalline cellulose once daily for four weeks. The placebo will be administered as a powder diluted in 300 mL of water and standardized to match the mode of presentation and administration of the experimental supplement. Participants will also complete the same supervised resistance training program three times per week on non-consecutive days. |
| Physically Inactive + Vicia faba Peptides | Experimental | Dietary Supplement: Vicia faba L.-derived peptides, Behavioral: Supervised Resistance TrainingPhysically inactive older adults randomized to receive 2.5 g/day of Vicia faba L.-derived peptides for four weeks. The supplement will be administered once daily as a powder diluted in 300 mL of water. Participants will also complete the same supervised resistance training program three times per week on non-consecutive days. |
| Physically Inactive + Placebo | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Supervised Resistance TrainingPhysically inactive older adults randomized to receive a placebo containing silicified microcrystalline cellulose once daily for four weeks. The placebo will be administered as a powder diluted in 300 mL of water and standardized to match the mode of presentation and administration of the experimental supplement. Participants will also complete the same supervised resistance training program three times per week on non-consecutive days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60 years or older;
- Classification as physically active or physically inactive according to the criteria established in the study;
- Clinical and functional conditions compatible with participation in the assessments and resistance training program;
- Availability to participate in the activities scheduled throughout the intervention period;
- Provision of written informed consent.
Key exclusion criteria (6 listed)
- Musculoskeletal injuries or conditions that prevent or compromise the safe performance of physical assessments or resistance training;
- Acute or uncontrolled clinical or psychiatric conditions that may compromise participant safety or adherence to the study protocol;
- Neurodegenerative diseases associated with relevant functional or cognitive impairment;
- Use of restrictive diets that may interfere with dietary intake or body composition outcomes;
- Use of medications specifically intended for weight loss;
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 |
|---|---|---|
| Vicia faba L.-derived peptidesParticipants assigned to the experimental intervention will receive 2.5 g/day of Vicia faba L.-derived peptides for four weeks. The supplement will be administered once daily as a powder using a measuring scoop containing the prescribed dose and diluted in 300 mL of drinking water. Participants will consume the supplement at home every day, including weekends. Containers will be returned at the end of the intervention to assess adherence. | Dietary supplement | Physically Active + Vicia faba Peptides, Physically Inactive + Vicia faba Peptides |
| PlaceboParticipants assigned to the placebo intervention will receive silicified microcrystalline cellulose once daily for four weeks. The placebo will be administered as a powder diluted in 300 mL of drinking water and will be standardized to match the mode of presentation and administration of the experimental supplement. Participants will consume the placebo at home every day, including weekends. Containers will be returned at the end of the intervention to assess adherence. | Dietary supplement | Physically Active + Placebo, Physically Inactive + Placebo |
| Supervised Resistance TrainingAll participants will complete a supervised resistance training program for four weeks, with three sessions per week performed on non-consecutive days. The program will target the major muscle groups of the upper and lower limbs using resistance-training equipment, free weights, and other available implements. Exercise prescription will be individualized according to each participant's functional capacity, previous experience, and clinical limitations. Training loads will be progressively adjusted throughout the intervention according to individual progress and exercise tolerance. | Behavioural | Physically Active + Placebo, Physically Active + Vicia faba Peptides, Physically Inactive + Placebo, Physically Inactive + Vicia faba Peptides |
Primary outcome
Change in Fat-Free Mass (kg)
Time frame: Baseline and after 4 weeks of intervention
Change in fat-free mass following the 4-week intervention. Fat-free mass will be assessed using multifrequency bioelectrical impedance analysis (InBody 570) under standardized pre-assessment conditions. Fat-free mass will be expressed in kilograms (kg).
11 secondary outcomes
Change in Handgrip Strength (kgf)
Time frame: Baseline and after 4 weeks of intervention
Change in Maximal Voluntary Isometric Contraction and Muscle Power during Knee Extension and Flexion
Time frame: Baseline and after 4 weeks of intervention
Change in Lower-Limb Strength Endurance (repetitions)
Time frame: Baseline and after 4 weeks of intervention
Change in Upper-Limb Muscle Power (meters)
Time frame: Baseline and after 4 weeks of intervention
Change in Dynamic Balance
Time frame: Baseline and after 4 weeks of intervention
Change in Self-Reported Functional Disability
Time frame: Baseline and after 4 weeks of intervention
Change in body fat percentage
Time frame: Baseline and after 4 weeks of intervention
Change in Vastus Lateralis and Rectus Femoris Muscle Thickness (cm)
Time frame: Baseline and after 4 weeks of intervention
Change in Physical Frailty Phenotype
Time frame: Baseline and after 4 weeks of intervention
Change in Intensity of Depressive Symptoms
Time frame: Baseline and after 4 weeks of intervention
Change in Quality of Life
Time frame: Baseline and after 4 weeks of intervention
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 7 Oct 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Vitor S Painelli, Dr principal investigator
Centro Universitário Cesumar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vicia faba L.-derived peptides and Supervised Resistance Training in people with Healthy Aging, run by Universidade Cesumar (UNICESUMAR) at 1 site in Brazil.
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 6 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: enrolling by invitation, as of the sponsor's last update on 7 Oct 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat-Free Mass (kg) (time frame: Baseline and after 4 weeks of intervention). 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 7 Oct 2026.