Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06172725
Other study ID # NL84531.018.23
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04655547 - Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance N/A
Completed NCT04744142 - Effects of Ketones on Muscle Wasting During Caloric Restriction in Lean Females N/A
Completed NCT03870425 - Distribution of Nutrient Derived Amino Acids N/A
Active, not recruiting NCT05355090 - Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics N/A
Completed NCT04764526 - Ice Cream Enriched With Protein and Positive Emotions N/A