NCT05353595

Brief Summary

Rationale: Consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. Conventional animal-based protein sources such as meat, poultry, fish, eggs, and dairy are considered high-quality sources of dietary protein. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands will be challenging. Consequently, there is a great interest in more sustainable alternatives for these high-quality protein sources. Edible insects have recently been proposed as a high quality source of dietary protein. Insects are produced on a more viable and sustainable commercial scale and, as such, may contribute to ensuring global food security. Insect derived proteins represent a protein source that combines high quality with a (more) sustainable production. Though insect proteins have been suggested as a solution to secure future global dietary protein needs, there little data to support the bioavailability of insect derived proteins and their capacity to stimulate post-exercise muscle protein synthesis rates in vivo in humans. Objective: To assess the impact of ingesting mealworm derived protein on muscle protein synthesis rates during recovery from aerobic exercise in a group healthy men and women Study design: randomized, counter-balanced, cross-over design Study population: 20 healthy lean (BMI 18.5-30 kg/m2) young males and females (age: 18-35 y inclusive). Intervention: Subjects will perform running exercise and consume either 0.38 g per kg bodyweight mealworm protein or a non-caloric placebo. In addition, continuous intravenous tracer infusions will be applied, with plasma and muscle samples collected. Main study parameters/endpoints: The primary outcome will be post-exercise muscle protein synthesis rates following beverage ingestion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

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

First Submitted

Initial submission to the registry

April 21, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

April 21, 2022

Last Update Submit

October 30, 2023

Conditions

Keywords

Dietary proteinInsect proteinmuscle protein synthesismuscle anabolismendurance exercise

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis rates

    Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.

    0-6 hours

Secondary Outcomes (6)

  • Muscle protein synthesis rates

    -3- 0 hours

  • Muscle protein synthesis rates

    0-3 hours

  • Muscle protein synthesis rates

    3-6 hours

  • Plasma glucose concentrations

    0-6 hours

  • Plasma insulin concentrations

    0-6 hours

  • +1 more secondary outcomes

Other Outcomes (9)

  • Age in year

    baseline

  • Dietary macronutrient intake

    2 days before test days

  • Body mass in kg

    baseline

  • +6 more other outcomes

Study Arms (2)

insect protein

EXPERIMENTAL

0.38g insect protein / kg body mass with vanilla flavouring is provided. In the morning the participant is weighed and based on this weight an independent researcher prepares the protein drink.

Dietary Supplement: Insect proteinBehavioral: Running exercise

placebo

PLACEBO COMPARATOR

participants receive the same amount of water (based on body weight) with vanilla flavouring. this drink is also prepared by an independent researcher.

Behavioral: Running exercise

Interventions

Insect proteinDIETARY_SUPPLEMENT

Insect protein concentrate retrieved from lesser mealworms.

insect protein

40 minutes of running on a treadmill at 70% heart rate corresponding Vo2peak

Also known as: treadmill running, endurance exercise
insect proteinplacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 - 35 y
  • BMI 18.5 - 30 kg/m2
  • Having given informed consent

You may not qualify if:

  • Participating in a structured (progressive) exercise program
  • Smoking regularly
  • Allergy to house dust mites or crustaceans
  • Diagnosed GI tract disorders or diseases
  • Diagnosed musculoskeletal disorders
  • Diagnosed metabolic disorders (e.g. diabetes)
  • Cardiovascular disease
  • Hypertension (blood pressure above 140/90 mmHg)
  • Donated blood 3 months prior to test day
  • Pregnant
  • Amenorrhea
  • Using third generation oral contraceptives
  • Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
  • Chronic use of gastric acid suppressing medication
  • Chronic use of anti-coagulants
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Interventions

Insect Proteins

Intervention Hierarchy (Ancestors)

Arthropod ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Luc JC van Loon, PhD

    Maastricht University Medical Centre+

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
protein and placebo are matched for flavour and provided in dark bottle. Independent person is responsible for drink randomization and preparation. Final blood and muscle analyses are performed by research personnel that was unaware of treatment allocation.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: randomized, counter-balanced, cross-over design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 29, 2022

Study Start

June 3, 2022

Primary Completion

September 21, 2023

Study Completion

September 21, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations