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

NCT ID: NCT06172725

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2025-06-27

Brief Summary

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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.

Detailed Description

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Conditions

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Protein Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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High-Protein Vegetarian Diet

High-protein vegetarian diet (no meat/fish)

Group Type EXPERIMENTAL

Dietary and exercise intervention

Intervention Type OTHER

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.

High-Protein Omnivorous Diet

High-protein omnivorous diet

Group Type ACTIVE_COMPARATOR

Dietary and exercise intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amsterdam University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Amsterdam University of Applied Sciences

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Sophie Louise van Oppenraaij, MSc

Role: CONTACT

0031648533764

Facility Contacts

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Sophie Louise van Oppenraaij, MSc

Role: primary

0031648533764

Peter Weijs, Professor

Role: backup

Other Identifiers

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NL84531.018.23

Identifier Type: -

Identifier Source: org_study_id

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