Sustainable Insect-based Protein Supplement in the Elderly: a Pilot Study (NCT07456319) | Clinical Trial Compass
CompletedNot Applicable
Sustainable Insect-based Protein Supplement in the Elderly: a Pilot Study
Spain30 participantsStarted 2024-05-01
Plain-language summary
This pilot randomized, double-blind, controlled trial evaluated the effects of a Tenebrio molitor-enriched protein biscuit combined with a structured physical activity program on cardiometabolic health in older adults. Participants aged 65 years and older were assigned to receive either insect-based or control biscuits following supervised exercise sessions for 28 days. Primary outcomes focused on changes in lipid profile, while secondary outcomes included anthropometric measures, body composition, blood pressure, physical function, glucose metabolism, hepatic function and inflammatory biomarkers.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 60 years
* Body mass index (BMI) between 18.5 and 30.0 kg/m²
* Mini-Mental State Examination (MMSE) score ≥ 16
* Independent in basic activities of daily living
* Mini Nutritional Assessment-Short Form (MNA-SF) score ≥ 8
* Ability to provide written informed consent
Exclusion Criteria:
* Food Neophobia Scale score \> 4
* Chronic diseases affecting metabolism or nutritional status
* Dependency or severe functional impairment
* Current or past use of medications or supplements affecting body weight or metabolic function
* Excessive alcohol consumption
* History of eating disorders or psychiatric illness
* Known food allergies (e.g., crustacean allergy) or celiac disease
* Inability or unwillingness to comply with study procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lipid profile
Timeframe: One month (baseline and after the intervention)