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Trials / Completed

CompletedNCT07456319

Sustainable Insect-based Protein Supplement in the Elderly: a Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Universitat Oberta de Catalunya · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Accepted

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.

Detailed description

Population aging and increasing environmental pressures on food systems underscore the need for sustainable dietary strategies that support healthy aging. Edible insects, such as Tenebrio molitor, provide high-quality protein with a substantially lower environmental footprint than conventional livestock and may represent a viable alternative protein source for older adults. This pilot randomized, double-blind, parallel, controlled study was conducted in community-dwelling adults aged 60 years and older recruited from the Barcelona metropolitan area. Participants were randomly assigned to either an insect-based protein supplementation group or a control group. Both groups participated in an identical supervised physical activity program consisting of strength and resistance exercises performed three times per week over a 28-day intervention period. The insect-based intervention consisted of three cookies per day, providing 35 g of Tenebrio molitor flour. Control cookies were wheat flour-based and matched for palatability and texture. Cookie consumption was supervised by a dietitian immediately after exercise sessions to ensure compliance. Participants were instructed to maintain their habitual diet and lifestyle throughout the study. Primary outcomes included changes in conventional lipid profile parameters. Secondary outcomes comprised body weight, body composition, blood pressure, muscle strength and physical performance, glucose metabolism, hepatic enzymes, inflammatory biomarkers, advanced lipoprotein profiling, and plasma low-molecular-weight metabolites. Dietary intake was assessed using 3-day food records, and fasting blood samples were collected at baseline and post-intervention. In addition, acceptability and organoleptic perception of the intervention products were evaluated using structured questionnaires, assessing taste, texture, appearance, and overall satisfaction. Gastrointestinal tolerance, including symptoms such as bloating, discomfort, and changes in bowel habits, was systematically recorded throughout the intervention. Participants' willingness to continue consuming the insect-based product after study completion was also assessed to explore feasibility and long-term adherence.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTINSECT - Protein suplement based on edible insect flourParticipants received a protein suplement in the form of cookies based on edible insect flour.
DIETARY_SUPPLEMENTControlControl placebo

Timeline

Start date
2024-05-01
Primary completion
2024-12-22
Completion
2024-12-22
First posted
2026-03-06
Last updated
2026-03-09

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07456319. Inclusion in this directory is not an endorsement.