Improvements by a Protein-Rich Plant-Based Diet and Resistance Exercise Program for Active Ageing

Protein Intake Clinical Trial

— IMPACT  

Official title:

Improvements by a Protein-Rich Plant-Based Diet and Resistance Exercise Program for Active Ageing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172725
• Other study ID #: NL84531.018.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: June 27, 2025

Study information

• Verified date: December 2023
• Source: Amsterdam University of Applied Sciences
• Contact: Sophie Louise van Oppenraaij, MSc
• Phone: 0031648533764
• Email: s.l.van.oppenraaij[@]hva.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. The 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 27, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 (Levey & Coresh, 2012), and/or diabetes)

• 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

Related Conditions & MeSH terms

• Protein Intake

Intervention

Other:
• Dietary and exercise intervention
The healthy older adults will follow a twelve-week high-protein vegetarian diet or high-protein omnivorous diet both in combination with a resistance exercise program. All participants will receive blended dietary counselling. Blended dietary counselling is based on tele-coaching and face-to-face coaching performed by dieticians.

Locations

Country	Name	City	State
Netherlands	Amsterdam University of Applied Sciences	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam University of Applied Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein intake	Protein intake	Three months