Vicia Faba Peptides and Resistance Training in the Elderly

NCT07858292 | Enrolling By Invitation

• 1 other identifier: 01401926.7.0000.5539
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Aging; Resistance Training; Dietary Supplements; Sarcopenia; Body Composition

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and after 4 weeks of intervention

Secondary Outcomes (11)

• Change in Handgrip Strength (kgf)

  Baseline and after 4 weeks of intervention

• Change in Maximal Voluntary Isometric Contraction and Muscle Power during Knee Extension and Flexion

  Baseline and after 4 weeks of intervention

• Change in Lower-Limb Strength Endurance (repetitions)

  Baseline and after 4 weeks of intervention

• Change in Upper-Limb Muscle Power (meters)

  Baseline and after 4 weeks of intervention

• Change in Dynamic Balance

  Baseline and after 4 weeks of intervention

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: Placebo; Behavioral: Supervised Resistance Training

Interventions

Vicia faba L.-derived peptides DIETARY_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.

Physically Active + Vicia faba Peptides; Physically Inactive + Vicia faba Peptides

Placebo DIETARY_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.

Physically Active + Placebo; Physically Inactive + Placebo

Supervised Resistance Training BEHAVIORAL

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.

Physically Active + Placebo; Physically Active + Vicia faba Peptides; Physically Inactive + Placebo; Physically Inactive + Vicia faba Peptides

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cesumar (UNICESUMAR): lead

Study Sites (1)

UniCesumar - Centro Universitário Cesumar

Maringá, Paraná, 87050-900, Brazil

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Vitor S Painelli, Dr

  Centro Universitário Cesumar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigators and outcome assessors will remain blinded to treatment allocation throughout the study. The allocation code will be maintained by a designated unblinded researcher who will not participate in outcome assessments. The Vicia faba L.-derived peptide supplement and placebo will be standardized in their mode of presentation and administration to preserve blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 5, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 7, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)