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Completed

NCT Number: NCT07456319

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

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.

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Key information

Conditions

Aging Behavior Cardiometabolic Health Motor Activity Nutrition Sustainable Diets

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UOC

Barcelona, 08018, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Dietary Supplement

Control placebo

Primary outcomes

  1. Lipid profile

    Time frame: One month (baseline and after the intervention)

    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.

Secondary outcomes

  1. Body Weight (Kg)

    Time frame: Baseline to 28 days

    Body weight will be measured in kilograms (kg) using a calibrated digital scale, with participants wearing light clothing and no shoes. The change in body weight will be calculated as the difference between baseline and Day 28 measurements

  2. Change in blood pressure (mmHg) .

    Time frame: Baseline to 28 days

    Changes in systolic and diastolic blood pressure will be assessed to evaluate the cardiovascular response to the dietary intervention throughout the study period. Blood pressure will be measured in millimeters of mercury (mmHg) at baseline and at Day 28, using a calibrated sphygmomanometer. Changes from baseline to Day 28 will be calculated for both systolic and diastolic values.

  3. Change in Handgrip Strength (kg)

    Time frame: Baseline to 28 days

    Handgrip strength will be measured in kilograms (kg) using a calibrated handheld dynamometer under standardized conditions. The outcome will be expressed as the maximum value obtained from repeated trials of the dominant hand. The change in handgrip strength will be calculated as the difference between baseline and Day 28 measurements. Higher values indicate greater muscle strength.

  4. Change in glucose (mg/dL).

    Time frame: Baseline to 28 days

    Changes in fasting blood glucose will be measured in milligrams per deciliter (mg/dL) to determine changes in glycemic control associated with the dietary intervention. Blood glucose concentrations will be measured at baseline and at Day 28, and changes from baseline to Day 28 will be calculated.

  5. Change in hepatic enzymes (ALT, AST, GGT)

    Time frame: Baseline to 28 days

    Serum hepatic enzymes (ALT, AST, and GGT) will be analyzed as markers of liver function and to explore potential effects of the intervention on hepatic metabolic health.

  6. Change in inflammatory biomarkers

    Time frame: Baseline to 28 days

    Circulating inflammatory biomarkers will be measured to evaluate changes in systemic inflammation in response to the intervention

  7. Change in plasma low molecular weight metabolite

    Time frame: Baseline to 28 days

    Plasma low molecular weight metabolites will be analyzed using metabolomic approaches to characterize metabolic changes associated with the intervention.

  8. Change in plasma and red blood cells fatty acids

    Time frame: Baseline to 28 days

    Fatty acid composition in plasma and red blood cells will be assessed to evaluate changes in lipid metabolism and fatty acid status following the intervention.

  9. Changes in Energy Intake (kcal/day)

    Time frame: Frame: Baseline to 28 days

    Dietary intake will be assessed using 3-day food records collected at baseline and during the last week of the intervention. Mean daily energy intake will be calculated and expressed in kilocalories per day (kcal/day) using EasyDiet software. The change in energy intake will be calculated as the difference between baseline and Day 28 values.

  10. Changes in Dietary Carbon Footprint (kg CO₂-eq/day)

    Time frame: Baseline to 28 days

    Dietary carbon footprint (kg CO₂-equivalents/day) will be estimated by linking reported food intake to a validated life cycle assessment database (Poore & Nemecek (via OWID) and WFLDB - World Food LCA Databas) Changes from baseline to the last week of intervention will be calculated.

  11. Change in Body Mass Index (kg/m²)

    Time frame: Baseline to Day 28

    Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Height will be measured at baseline using a calibrated digital scale. Changes in BMI will be calculated as the difference between baseline and Day 28 values.

  12. Change in Body Fat Percentage (%)

    Time frame: Baseline to Day 28

    Body fat percentage (%) will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions. The change in body fat percentage will be calculated as the difference between baseline and Day 28 measurements.

  13. Change in Lean Mass Percentage (%)

    Time frame: Baseline to Day 28

    Lean mass percentage (%) will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions. The change in lean mass percentage will be calculated as the difference between baseline and Day 28 measurements.

  14. Change in Vivifrail Physical Performance Battery Total Score (points)

    Time frame: Baseline to Day 28

    Changes in physical performance will be assessed using the Vivifrail Physical Performance Battery (VPPB), a standardized functional assessment that evaluates lower-limb strength, balance, gait speed, and functional capacity in older adults.

    The total score ranges from 0 to 12 points, with higher scores indicating better physical performance. The primary outcome will be the change in the total VPPB score, calculated as the difference between baseline and Day 28 measurements.

    [Time Frame: Baseline to Day 28].

  15. Change in Protein Intake (g/day)

    Time frame: Baseline to Day 28

    Dietary intake will be assessed using 3-day food records collected at baseline and during the last week of the intervention. Mean daily protein intake will be calculated and expressed in grams per day (g/day) using EasyDiet software. The change in protein intake will be calculated as the difference between baseline and Day 28 values.

Sponsors and collaborators

Lead sponsor

Universitat Oberta de Catalunya

Other

Registry information

Acronym: SIPSE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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