- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06172725
Improvements by a Protein-rich Plant-based Diet and Resistance Exercise Program for Active Ageing (IMPACT)
February 18, 2026 updated by: Amsterdam University of Applied Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Holland
-
Amsterdam, North Holland, Netherlands, 1067 SM
- Amsterdam University of Applied Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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), 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-Protein Vegetarian Diet
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).
|
All participants will follow a resistance exercise program (3/week), which is personally guided by trainers.
|
|
Active Comparator: High-Protein Omnivorous Diet
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).
|
All participants will follow a resistance exercise program (3/week), which is personally guided by trainers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Protein intake
Time Frame: Three months
|
Protein intake
|
Three months
|
|
Appendicular lean mass
Time Frame: Three months
|
Appendicular lean mass (DXA)
|
Three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2024
Primary Completion (Actual)
June 27, 2025
Study Completion (Actual)
June 27, 2025
Study Registration Dates
First Submitted
December 7, 2023
First Submitted That Met QC Criteria
December 7, 2023
First Posted (Actual)
December 15, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2026
Last Update Submitted That Met QC Criteria
February 18, 2026
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- NL84531.018.23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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