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

NCT07456319 | Completed

• 2 other identifiers: RA2024RA2024.
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Nutrition; Sustainable Diets; Cardiometabolic Health

Keywords

Feasibility trial; Edible insects; Tenebrio molitor; Older adults; Protein supplementation; Cardiometabolic health; Sustainable nutrition; Physical activity

Outcome Measures

Primary Outcomes (1)

• Lipid profile

  Changes in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) and lipid particles (small, medium and large lipoproteins) Description: Changes in the lipid profile were assessed by measuring fasting plasma concentrations of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides at baseline and after the intervention. In addition, detailed lipoprotein particle profiling was performed to quantify the concentration and size distribution of lipoproteins, including small, medium, and large subclasses of LDL, HDL, and very-low-density lipoproteins (VLDL). These measures allowed evaluation of both conventional lipid parameters and qualitative changes in lipoprotein particle composition associated with the intervention.

  One month (baseline and after the intervention)

Secondary Outcomes (15)

• Body Weight (Kg)

  Baseline to 28 days

• Change in blood pressure (mmHg) .

  Baseline to 28 days

• Change in Handgrip Strength (kg)

  Baseline to 28 days

• Change in glucose (mg/dL).

  Baseline to 28 days

• Change in hepatic enzymes (ALT, AST, GGT)

  Baseline to 28 days

Study Arms (2)

INSECT

EXPERIMENTAL

Participants consumed three Tenebrio molitor-enriched cookies per day (35 g insect flour/day) immediately after supervised exercise sessions, three times per week for 28 days.

Dietary Supplement: INSECT - Protein suplement based on edible insect flour

CONTROL

PLACEBO COMPARATOR

Participants consumed three wheat flour-based control cookies per day immediately after supervised exercise sessions, three times per week for 28 days.

Dietary Supplement: Control

Interventions

INSECT - Protein suplement based on edible insect flour DIETARY_SUPPLEMENT

Participants received a protein suplement in the form of cookies based on edible insect flour.

INSECT

Control DIETARY_SUPPLEMENT

Control placebo

CONTROL

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Oberta de Catalunya: lead

Study Sites (1)

UOC

Barcelona, Barcelona, 08018, Spain

Location

Related Publications (4)

• Ros-Baro M, Puig MC, Chiva-Blanch G, Diaz-Rizzolo DA, Martinez AA, Rafart MJ, Chiriac I, Rogel MB, Cunill MP, Casas-Agustench P, Bach-Faig A. Enrichment of Pasteurized Dairy Product and Brownie With Edible Insect (Tenebrio molitor) to Analyze Acceptance Using Check-All-That-Apply Methodology. Food Sci Nutr. 2025 Oct 30;13(11):e70925. doi: 10.1002/fsn3.70925. eCollection 2025 Nov.

  PMID: 41179365 BACKGROUND

• Ros-Baro M, Casas-Agustench P, Diaz-Rizzolo DA, Batlle-Bayer L, Adria-Acosta F, Aguilar-Martinez A, Medina FX, Pujola M, Bach-Faig A. Edible Insect Consumption for Human and Planetary Health: A Systematic Review. Int J Environ Res Public Health. 2022 Sep 15;19(18):11653. doi: 10.3390/ijerph191811653.

  PMID: 36141915 BACKGROUND

• Ros-Baro M, Sanchez-Socarras V, Santos-Pages M, Bach-Faig A, Aguilar-Martinez A. Consumers' Acceptability and Perception of Edible Insects as an Emerging Protein Source. Int J Environ Res Public Health. 2022 Nov 26;19(23):15756. doi: 10.3390/ijerph192315756.

  PMID: 36497830 BACKGROUND

• Ishara J, Ekaette I, Matendo R, Vandenberg G, Niassy S, Katcho K, Kinyuru J. Potential health benefits of insect bioactive metabolites and consumer attitudes towards edible insects. NPJ Sci Food. 2025 Sep 26;9(1):195. doi: 10.1038/s41538-025-00549-x.

  PMID: 41006283 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators were blinded to group allocation. Intervention cookies were similar in appearance, texture, and palatability.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was designed as a parallel, randomized, double-blind clinical trial. Participants were randomly assigned to one of two intervention arms: an insect-based protein supplementation group (INSECT) or a control group (CONTROL), both combined with the same structured and supervised physical activity program. Randomization was performed using a computerized system, and both participants and investigators were blinded to group allocation. The dietary intervention consisted of three cookies per day, consumed on each exercise day immediately after the training session (within 15 minutes post-exercise). In the INSECT group, the cookies provided 35 g/day of Tenebrio molitor flour, corresponding to 23.6 g of total protein (20.3 g animal protein and 3.3 g plant protein). In the CONTROL group, the cookies provided 6.5 g/day of total protein, entirely of plant origin. The INSECT cookies weighed 104 g/day and provided 274 kcal, whereas CONTROL cookies weighed 103 g/day and provided 399 kcal

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 6, 2026
• Study Start: May 1, 2024
• Primary Completion: December 22, 2024
• Study Completion: December 22, 2024
• Last Updated: March 9, 2026

Record last verified: 2026-02

Locations

ES (1)