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Sustainable Diets in Families in Copenhagen

Sustainable Diets in Families in Copenhagen - Menus With Alternative Proteins Meals

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05156853
Acronym
SUSINCHAIN
Enrollment
160
Registered
2021-12-14
Start date
2022-08-01
Completion date
2023-09-30
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insect Proteins

Keywords

Insect proteins, Alternative proteins, Human intervention study, Novel food acceptance

Brief 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.

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).

Interventions

DIETARY_SUPPLEMENTInsect menus

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.

DIETARY_SUPPLEMENTPlant menus

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.

Sponsors

European Commission
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the taste and nature of the intervention foods, blinding of study staff and participants is not possible during this study.

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

This study recruits families in which one adult and one child are enrolled as participants. Adults must: * Be healthy. * Determined from the self-reported medical history or when a clinical condition exists, when this is considered to be irrelevant (i.e. not influencing the safety for the participant or study outcomes) for the study by the study medical doctor. * Eat meat for dinner at least 5 days a week in average. * Be willing to consume insect- and plant-based foods. * Be able to talk, read and understand Danish in order to understand the study procedures properly. * Have basic computer competence. * Have freezer capacity for two weeks of food. * If the custody holders of a child, who wants to participant, do not want to participate, another adult from the household can participate. It is still the custody holders who are responsible for the child's participation in the study. Children must: * Be healthy. * Determined from the self-reported medical history or when a clinical condition exists, when this is considered to be irrelevant (i.e. not influencing the safety for the participant or study outcomes) for the study by the study medical doctor. * Eat meat for dinner at least 5 days a week in average. * Age: 8-10 years. * Be able to talk and understand Danish in order to understand the study procedures properly. * Be willing to consume insect- and plant-based foods.

Exclusion criteria

(adult and child): 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in intake of total daily amount of meat protein at baseline and endline6 weeksData from 4 days dietary registration at each time-point
Change in proportion of meat protein of the total protein intake6 weeksMeat 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 products6 weeksAssessed during baseline week and each intervention week, including week of endline assessment

Secondary

MeasureTime frameDescription
Change in the sensory evaluation of the intervention foods6 weeksChanges 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.

Countries

Denmark

Contacts

Primary ContactNanna Roos, Associate Professer
nro@nexs.ku.dk+4535332497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026