Clinical trial NCT05156853: Sustainable Diets in Families in Copenhagen
Official title: Sustainable Diets in Families in Copenhagen - Menus With Alternative Proteins Meals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insect Proteins
Keywords: Insect proteins
Alternative proteins
Human intervention study
Novel food acceptance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2021-12-14
Enrollment: 160
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: Change in intake of total daily amount of meat protein at baseline and endline
timeFrame: 6 weeks
measure: Change in proportion of meat protein of the total protein intake
timeFrame: 6 weeks
measure: Counts of main meals with meat and alternative protein products
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in the sensory evaluation of the intervention foods
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: University of Copenhagen - Department of Nutrition, Exercise and Sports
Study officials:
References: