Improvements by a Protein-rich Plant-based Diet and Resistance Exercise Program for Active Ageing

NCT06172725 | Completed DMC

• 1 other identifier: NL84531.018.23
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

High-protein intake and physical activity are important approaches to preserve muscle mass. Consuming high levels of high-quality proteins to preserve muscle mass is challenging with a plant-based diet. Healthy, older participants will follow a twelve-week high-protein vegetarian diet or high-protein omnivorous diet both in combination with a resistance training program. The change in protein intake and muscle mass will be assessed.

Conditions

Protein Intake

Outcome Measures

Primary Outcomes (2)

• Protein intake

  Protein intake

  Three months

• Appendicular lean mass

  Appendicular lean mass (DXA)

  Three months

Study Arms (2)

High-Protein Vegetarian Diet

EXPERIMENTAL

High-protein vegetarian diet (no meat/fish). All participants will receive blended dietary counselling. Blended dietary counselling is based on tele-coaching and face-to-face coaching performed by dieticians (in training).

Other: Resistance exercise intervention

High-Protein Omnivorous Diet

ACTIVE COMPARATOR

High-protein omnivorous diet. All participants will receive blended dietary counselling. Blended dietary counselling is based on tele-coaching and face-to-face coaching performed by dieticians (in training).

Other: Resistance exercise intervention

Interventions

Resistance exercise intervention OTHER

All participants will follow a resistance exercise program (3/week), which is personally guided by trainers.

High-Protein Omnivorous Diet; High-Protein Vegetarian Diet

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 55 years or older
• BMI 18.5-30 kg/m2
• Living independently
• Ability and willingness to comply with the protocol
• Written an informed consent
• Consent of the study physician

You may not qualify if:

• Alcohol abuse (more than 14 glasses per week (women) or more than 21 glasses per week (men)) or drug abuse in the opinion of the study physician (CBS et al., 2017)
• Inability to understand the Dutch language
• Cognitive impairment (MMSE more than 25)
• Diagnosed chronic disease that may interfere with protocol (e.g., cardiovascular, gastrointestinal, neurological, known renal diseases (eGFR more than 60 mL/min), and/or diabetes)
• Underwent bariatric surgery
• Current enrolment in an exercise program or other intervention study
• Planned a holiday during the intervention period and is unable to attend training sessions for more than 1 week

Sponsors & Collaborators

• Amsterdam University of Applied Sciences: lead

Study Sites (1)

Amsterdam University of Applied Sciences

Amsterdam, North Holland, 1067 SM, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: March 11, 2024
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: February 20, 2026

Record last verified: 2023-12

Locations

NL (1)