Insect ProteinsSUSINCHAINNCT05156853
Sustainable Diets in Families in Copenhagen
A study testing Insect menus and Plant menus in people with Insect Proteins, run by University of Copenhagen at 1 site in Denmark.
Trial summary
SUSINCHAIN investigates the impact of exposing families (an adult and a child) to meals with alternative proteins (insect-based or plant-based products) on dietary pattern, intake of meat and total protein. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Insect Proteins
- What is being tested?
- Insect menus and Plant menus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Individuals will be excluded if they have:
- Possess any food allergies or intolerances.
- Possess a dust mite allergy or intolerance.
- Follow one or more restricted diets (veganism, gluten-free, keto, vegetarianism, etc.).
- Use protein supplements, such as whey protein powder.
- Participation in other clinical studies.
Show all 13Show fewer
- Gastrointestinal, kidney or liver disorders.
- Chronic inflammation disorders (excluding obesity).
- Diagnosed psychiatric disorder including depression requiring treatment, but can be accepted in judgement with the daily study manager, site-PI, PI or clinical responsible.
- Systematic antibiotic use < 1 month prior to the study.
- Lack of abilities (physical and psychological) to be complied with the procedures in the protocol, as evaluated by the daily study manager, site-PI, PI or clinical responsible.
- Pregnant or lactating within the study period.
- Self-reported use of drugs of abuse within the previous 12 months, including cannabis.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University of Copenhagen - Department of Nutrition, Exercise and Sports
Frederiksberg, 1958
Nanna Roos
About this study
Official title: Sustainable Diets in Families in Copenhagen - Menus With Alternative Proteins Meals
SUSINCHAIN investigates the impact of exposing families (an adult and a child) to meals with alternative proteins (insect-based or plant-based products) on dietary pattern, intake of meat and total protein.
Read the detailed description
The overall objective of this study is to investigate the impact of exposing paired participants (an adult and a child) to dinner menus of meals with alternative proteins (insect-based or plant-based products) on dietary pattern, intake of meat, and protein over a six-week intervention period. The insect-based menu is the experimental exposure and the plant-based menu is the positive control menu.
The hypothesis is that test menus of meals with alternative proteins will replace the meat consumed during dinner, resulting in maintaining the total protein intake while replacing 20% of the meat protein with alternative protein on a weekly basis.
The assumption is that the insect-based menus will replace meat protein similarly or to a larger extend than the positive control group receiving the comparable plant-based menu. The inclusion of the positive control group allows us to isolate the specific impact of exposure to insect-based menu from the exposure to dietary change of more familiar plant-based products.
The study is a randomized intervention trial recruiting 80 paired participants of an adult and a child age 8-10 year living together in a family, alone or with other family members. The paired participants are randomized to receive one of two menus of meals with alternative proteins, either plant-based or insect-based. Measurements (dietary records, questionnaires) as well as biological samples (urine collection) are taken primarily at baseline (week 0) and endline (week 6).
- Conditions
- Insect Proteins
- Being tested
- Insect menus, Plant menus
- Keywords
- Insect proteins, Alternative proteins, Human intervention study, Novel food acceptance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insect menusDietary supplement
The insect menus will consist of 6 different products: flatbread, spice-mix, paste, minced meat, sausage and falafels. The products are based on either crickets, mealworms or buffaloworm larvae.
Plant menusDietary supplement
The plant menus will be based on products which can be purchased in normal supermarkets and chosen to be as equal to the insect-based products as possible.
| Study group | Role | What they receive |
|---|---|---|
| Insect-based menu | Experimental | Replacement of meat proteins with insect-based alternatives at main meals 3 times weekly. Receives: Dietary Supplement: Insect menus |
| Plant-based menu | Active comparator | Replacement of meat proteins with plant-based alternatives at main meals 3 times weekly. Receives: Dietary Supplement: Plant menus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intake of total daily amount of meat protein at baseline and endline
Data from 4 days dietary registration at each time-point
Measured: 6 weeks
Change in proportion of meat protein of the total protein intake
Meat intake assessed by 4 day dietary registration, total protein intake assessed by 4 day dietary registration with biochemical validation by spot urine N excretion
Measured: 6 weeks
Counts of main meals with meat and alternative protein products
Assessed during baseline week and each intervention week, including week of endline assessment
Measured: 6 weeks
Secondary outcomes (1)
Change in the sensory evaluation of the intervention foods
Changes in the sensory parameters for liking of the intervention food measured on Likert scale from 1 (extremely bad) to 7 (extremely good), meaning the higher score, the higher liking of the intervention food. Each paired participants are randomized to assess two of the six products at the first intervention week and the last intervention week.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Aug 2022
- Primary completion28 Apr 2023
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insect ProteinsStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Nanna Roos, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156853
- Sponsor's protocol ID
- D229
- Acronym
- SUSINCHAIN
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maya C, Wilderspin DE, Costa AIA, Cunha LM, Roos N. Introducing menus of three weekly insect- or plant-based dinner meals slightly reduced meat consumption in Danish families: Results of a randomized intervention study. Appetite. 2024 Dec 1;203:107689. doi: 10.1016/j.appet.2024.107689. Epub 2024 Oct 1.
PubMed 39357104Maya C, Cunha LM, de Almeida Costa AI, Veldkamp T, Roos N. Introducing insect- or plant-based dinner meals to families in Denmark: study protocol for a randomized intervention trial. Trials. 2022 Dec 20;23(1):1028. doi: 10.1186/s13063-022-07000-6.
PubMed 36539897
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Diets in Families in Copenhagen - Menus With Alternative Proteins Meals
- ClinicalTrials.gov ID
- NCT05156853
- Acronym / sponsor ID
- SUSINCHAIN / D229
- Conditions
- Insect Proteins
- Keywords
- Insect proteins, Alternative proteins, Human intervention study, Novel food acceptance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SUSINCHAIN investigates the impact of exposing families (an adult and a child) to meals with alternative proteins (insect-based or plant-based products) on dietary pattern, intake of meat and total protein.
Detailed description
The overall objective of this study is to investigate the impact of exposing paired participants (an adult and a child) to dinner menus of meals with alternative proteins (insect-based or plant-based products) on dietary pattern, intake of meat, and protein over a six-week intervention period. The insect-based menu is the experimental exposure and the plant-based menu is the positive control menu.
The hypothesis is that test menus of meals with alternative proteins will replace the meat consumed during dinner, resulting in maintaining the total protein intake while replacing 20% of the meat protein with alternative protein on a weekly basis.
The assumption is that the insect-based menus will replace meat protein similarly or to a larger extend than the positive control group receiving the comparable plant-based menu. The inclusion of the positive control group allows us to isolate the specific impact of exposure to insect-based menu from the exposure to dietary change of more familiar plant-based products.
The study is a randomized intervention trial recruiting 80 paired participants of an adult and a child age 8-10 year living together in a family, alone or with other family members. The paired participants are randomized to receive one of two menus of meals with alternative proteins, either plant-based or insect-based. Measurements (dietary records, questionnaires) as well as biological samples (urine collection) are taken primarily at baseline (week 0) and endline (week 6).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insect-based menu | Experimental | Dietary Supplement: Insect menusReplacement of meat proteins with insect-based alternatives at main meals 3 times weekly. |
| Plant-based menu | Active comparator | Dietary Supplement: Plant menusReplacement of meat proteins with plant-based alternatives at main meals 3 times weekly. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Possess any food allergies or intolerances.
- Possess a dust mite allergy or intolerance.
- Follow one or more restricted diets (veganism, gluten-free, keto, vegetarianism, etc.).
- Use protein supplements, such as whey protein powder.
- Participation in other clinical studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insect menusThe insect menus will consist of 6 different products: flatbread, spice-mix, paste, minced meat, sausage and falafels. The products are based on either crickets, mealworms or buffaloworm larvae. | Dietary supplement | Insect-based menu |
| Plant menusThe plant menus will be based on products which can be purchased in normal supermarkets and chosen to be as equal to the insect-based products as possible. | Dietary supplement | Plant-based menu |
Primary outcome
Change in intake of total daily amount of meat protein at baseline and endline
Time frame: 6 weeks
Data from 4 days dietary registration at each time-point
Change in proportion of meat protein of the total protein intake
Time frame: 6 weeks
Meat intake assessed by 4 day dietary registration, total protein intake assessed by 4 day dietary registration with biochemical validation by spot urine N excretion
Counts of main meals with meat and alternative protein products
Time frame: 6 weeks
Assessed during baseline week and each intervention week, including week of endline assessment
1 secondary outcome
Change in the sensory evaluation of the intervention foods
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 39357104Maya C, Wilderspin DE, Costa AIA, Cunha LM, Roos N. Introducing menus of three weekly insect- or plant-based dinner meals slightly reduced meat consumption in Danish families: Results of a randomized intervention study. Appetite. 2024 Dec 1;203:107689. doi: 10.1016/j.appet.2024.107689. Epub 2024 Oct 1.
- Derived from this study: PubMed 36539897Maya C, Cunha LM, de Almeida Costa AI, Veldkamp T, Roos N. Introducing insect- or plant-based dinner meals to families in Denmark: study protocol for a randomized intervention trial. Trials. 2022 Dec 20;23(1):1028. doi: 10.1186/s13063-022-07000-6.
- Individual participant dataSharing planned: No
Related trials for Insect Proteins
Recruiting
Sustainable and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)
Food Preferences, Satiety and Food Intake
Recruiting
Insect vs Animal Protein for Building Muscle
Cricket Protein, Whey Protein
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insect menus and Plant menus in people with Insect Proteins, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nanna Roos, Associate Professer (+4535332497, nro@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intake of total daily amount of meat protein at baseline and endline (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05156853, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.