Sustainable Diets in Families in Copenhagen (SUSINCHAIN)

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.

Study Overview

• Status: Recruiting
• Conditions: Insect Proteins
• Intervention / Treatment: Dietary supplement: Insect menus; Dietary supplement: Plant menus

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nanna Roos, Associate Professer; Phone Number: +4535332497; Email: nro@nexs.ku.dk

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1958
    • Recruiting
    • University of Copenhagen - Department of Nutrition, Exercise and Sports
    • Contact: Nanna Roos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insect-based menu; Replacement of meat proteins with insect-based alternatives at main meals 3 times weekly.	Dietary supplement: Insect 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.
Active Comparator: Plant-based menu; Replacement of meat proteins with plant-based alternatives at main meals 3 times weekly.	Dietary supplement: Plant 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intake of total daily amount of meat protein at baseline and endline	Data from 4 days dietary registration at each time-point	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	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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: European Commission

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Insect proteins; Alternative proteins; Human intervention study; Novel food acceptance
• Other Study ID Numbers: D229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No