Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT03712306
Eligibility Criteria:
Inclusion criteria:
* Age ≥ 65 years;
* Community-dwelling;
* Lower protein intake defined as both a probability score above a certain cutoff on the protein screener (www.proteinscreener.nl) as well as based on actual protein intake assessed by 24-hour recalls. The protein screener was developed and validated using an extended FFQ among Dutch older adults. The cutoff will be chosen based on results of different studies in which the investigators compare the probability scores of the protein screener with protein intake as measured with food diaries and/or dietary recalls. The investigators will then choose the probability score that is most closely associated with a protein intake \< 1.0 g/kg adjusted body weight/day. This probably score reflects older adults with a higher probability on a protein intake \< 1.0 g/kg adjusted body weight/d than a general sample of older adults;
Exclusion criteria:
* Inability or unwillingness to provide informed consent
* Not able to eat independently;
* Not able to speak, write and read the Dutch language;
* Current participation to supervised behavioral or lifestyle intervention that intervenes with PROMISS intervention;
* Not able the visit the research site in the following next 6 months;
* Bedridden or wheelchair bound;
* Individuals who do not go outside;
* Diagnosed with severe kidney disease;
* Diagnosed with Parkinson's disease;
* Diagnosed with diabetes mellitus type I;
* Diagnosed with diabetes mellitus type 2 and starting with insulin;
* Current treatment of cancer (with the exception of basal cell carcinoma);
* Vegan diet;
* Severe allergies to certain food products (such as peanuts, gluten);
* Diagnosed with an eating disorder (self-reported);
* Purposefully lost/gained \> 3 kg in the past three months
* Heart problems in the past three months (heart attack, angioplasty, heart surgery, stroke or other serious heart disease)
* Not able to complete the 400 meter walk test within 15 minutes (self-reported, and assessed at study baseline).
* Alcohol abuse past 6 months (AUDIT-C ≥ 2);
* Low cognitive status, defined as the mini-mental state examination (MMSE) score ≤ 20
* BMI \< 18.5 kg/m2 (self-reported, and assessed at study baseline);
* Overweight, defined as BMI \> 32.0 kg/m2 (self-reported, and assessed at study baseline);
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03712306
Study Brief:
Protocol Section:
NCT03712306