NCT07415408

Brief Summary

Rationale: Sufficient dietary protein intake helps to preserve muscle mass and strength and is a key factor in healthy ageing. Achieving an increased protein intake with regular food products has shown to be a challenge for many older adults. Applying behavioural change techniques may facilitate a more sustained improvement in protein consumption over time. Objective: To investigate whether a nutritional app intervention can increase the protein intake (with the goal of 1.2 g/kg body weight/day) of older adults, using readily available food products. Secondary and tertiary objective include the effects of the intervention on body composition and muscle strength and long-term effects on protein intake.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 17, 2026

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

November 14, 2025

Last Update Submit

February 16, 2026

Conditions

Keywords

dietary proteinehealthappnutritionolder adultselderlystrength exercisewhole foods

Outcome Measures

Primary Outcomes (1)

  • protein intake

    Δprotein intake relative to bodyweight (g/kg/d)

    baseline (0 months), post-intervention (3 months) and follow-up (6 months)

Secondary Outcomes (7)

  • muscle mass

    baseline (0 months), post-intervention (3 months) and follow-up (6 months)

  • Leg muscle strength

    [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

  • Attitude towards physical activity

    [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

  • Attitude towards a healthy diet

    [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

  • Functional leg muscle strength

    [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

  • +2 more secondary outcomes

Other Outcomes (10)

  • Muscle strengthening activity and frequency

    [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

  • Muscle strengthening activity duration

    [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

  • Muscle strengthening activity types

    [Time Frame: baseline (0 months), post-intervention (3 months) and follow-up (6 months)]

  • +7 more other outcomes

Study Arms (2)

Protein and exercise

EXPERIMENTAL

Only the intervention group is coached to sustainable changes in (1) the amount of protein intake (goal: 1.2 g/kg body weight/d) and (2) the efficiency of protein intake with a focus on high-quality proteins, variety in protein sources, and timing of intake. To increase applicability in daily life, we aim to achieve these goals using readily available protein products. Participants in both groups have access to the application that contains a wide range of muscle and bone-strengthening activities, as well as balance exercises that can be performed independently at home.

Behavioral: Nutritional coaching via an appBehavioral: Exercise recommendations

Exercise

ACTIVE COMPARATOR

Participants have only access to the application that contains a wide range of muscle and bone-strengthening activities, as well as balance exercises that can be performed independently at home. Participants do not receive nutritional recommendations.

Behavioral: Exercise recommendations

Interventions

Coaching involves e-coaching via an app, supported by one telephone consultation. Within the SO-NUTS (preventing obesity, sarcopenia, and Sarcopenic Obesity in retirement through digital, personalised interventions for healthy NUTrition and physical activity for Seniors) project, BCTs are investigated that fit the older adult population. Insights gained from systematic review and focus group interviews are applied to the Eifit application.

Protein and exercise

The objective is to adhere to the 2017 physical activity guidelines as set by the Health Council of the Netherlands i.e. "Engage in at least 150 minutes of moderate-intensity physical activity per week, perform muscle- and bone-strengthening activities at least twice a week in combination with balance exercises, and avoid prolonged periods of sitting." Participants in both groups have access to the application that contains a wide range of muscle and bone-strengthening activities, as well as balance exercises that can be performed independently at home. Activities such as walking, cycling, tennis, or swimming can also be added. Participants can monitor their progress themselves, and if desired, push notifications, tips, and reminders can be sent.

ExerciseProtein and exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to use a smartphone;
  • Open to make use of an application;
  • Open to alter their diet;
  • Able to understand and perform the study procedures;
  • Sufficient command of the Dutch language.

You may not qualify if:

  • Comorbidities where physical activity and/or a certain intake may be dangerous (e.g., diagnosed kidney failure);
  • Pre-scribed diet (e.g. low sodium or low potassium diet) or plant-based diet;
  • Use of nutritional shakes (such as meal replacements or protein shakes) during the study period. The use of nutritional supplements (such as iron or vitamin D tablets) is permitted and will be requested.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, 6525 GC, Netherlands

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants in the exercise (active comparator) group are blinded to the real purpose of the study being 'to improve protein intake' to limit subjects bias. Meaning that the participants in the exercise group will also change their diet including their protein intake.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

February 17, 2026

Study Start

January 12, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 17, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations