Sustainable Diets in Families in Copenhagen (SUSINCHAIN)

University of Copenhagen

Status: Enrolling

Conditions: Insect Proteins

Treatments: Dietary Supplement: Plant menus; Dietary Supplement: Insect menus

Study type: Interventional

Funder types: Other

Identifiers

NCT05156853

D229

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Exclusion criteria related to adults:

• Pregnant or lactating within the study period.
• Self-reported use of drugs of abuse within the previous 12 months, including cannabis.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Insect-based menu

Experimental group

Description:

Replacement of meat proteins with insect-based alternatives at main meals 3 times weekly.

Treatment:

Dietary Supplement: Insect menus

Plant-based menu

Active Comparator group

Description:

Replacement of meat proteins with plant-based alternatives at main meals 3 times weekly.

Treatment:

Dietary Supplement: Plant menus