NCT06906159

Brief Summary

A global shift towards sustainable food sources is now emerging, largely due to the immense environmental pressure that comes from producing animal foods, particularly beef. Insects present a novel source of sustainable dietary protein due to their high protein content. This is particularly relevant for older adults, as protein becomes increasingly more important in later life. It helps to maintain muscle as we age, which is crucial for reducing frailty, falls and early mortality. We want to find out more about the digestion and absorption of insect protein in older people to see if it could be a beneficial source of protein to help maintain muscle. We are interested in the use of insect-based solid foods, especially the use of flour made from grounded whole crickets. We want to explore the digestibility of cricket protein compared to a commonly used animal alternative (whey protein) to find out if it can be efficiently absorbed and utilised within humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

January 8, 2025

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gastric emptying

    Exhaled breath is used to assess the rate of gastric emptying of the protein muffins

    4 hour post-prandial period

  • Plasma amino acids

    Blood samples are used to assess the plasma amino acid response to consuming the protein muffins

    4 hour post-prandial period

Secondary Outcomes (1)

  • Metabolic markers

    4 hour post-prandial period

Study Arms (2)

Cricket muffin

EXPERIMENTAL

Muffin made with cricket-derived protein powder

Dietary Supplement: Cricket protein

Whey muffin

ACTIVE COMPARATOR

Muffin made with whey protein powder

Dietary Supplement: Whey protein

Interventions

Cricket proteinDIETARY_SUPPLEMENT

Muffins made with cricket-derived protein from house crickets (Acheta domesticus )

Cricket muffin
Whey proteinDIETARY_SUPPLEMENT

Muffins made with whey protein

Whey muffin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult males and females in general good health, aged between 18 - 35 years, 40 - 55 years or over 65 years
  • BMI between 18.5 and 35 kg/m2
  • Stable weight for at least 3 months
  • Volunteers must be able and willing to give informed written consent
  • Volunteers must be able to eat egg
  • Volunteers must be willing to provide blood samples

You may not qualify if:

  • Current or previous gastrointestinal conditions (e.g. Crohn's disease, Coeliac disease, Irritable Bowel Syndrome) - assessed via a health questionnaire
  • Those with diabetes or other metabolic conditions - assessed via a health questionnaire
  • Those taking food supplements which may impact digestion (e.g., digestive enzymes, probiotics, fibre supplements)
  • Those smoking, using nicotine products (e.g., e-cigarettes, patches) or not abstained from these activities for more than 6 months - assessed via a health questionnaire
  • Pregnant or lactating
  • Volunteers with a high daily caffeine intake \> 300 mg/day (more than 5 cups of standard coffee per day)
  • Drug or alcohol abuse in the last 2 years
  • Those who are currently taking part in a clinical trial or another research study or have taken part within the last 3 months
  • Those with food allergies, dietary intolerance or Coeliac disease - assessed via a health questionnaire
  • Those following weight loss diets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

MeSH Terms

Interventions

capsid protein, Cricket paralysis virusWhey Proteins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • James Rutherford, MSc

    University of Surrey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
One member of the research team is in charge if blinding the muffins to 'A' and 'B'
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Repeated measures randomised crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

April 2, 2025

Study Start

March 11, 2024

Primary Completion

March 10, 2025

Study Completion

March 10, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations