NCT06714656

Brief Summary

Food represents one of the greatest health and environmental challenges of the 21st century. Consuming less of the most environmentally damaging foods, such as meat, is considered an effective method to reduce food-related greenhouse gas emissions. The aim of these N-of-1 FOOD SWAP intervention studies is to investigate whether and which physiological, psychological and environmental factors, at an individual level, modify the adoption and adherence of food swaps aiming to reduce the intake of red meat and replace this with fish or plant-based foods, in young adults. The series of N-of-1 studies will also assess whether an 8-week food swap intervention will improve general health markers such as blood pressure, plasma lipids and glucose, and blood/urinary metabotype. This approach will provide insight into physiological, behavioural and environmental factors that can help explain individual fluctuations in adherence and physiological outcomes common in nutrition studies. In the future, this should enable us to tailor how we deliver effective individualised interventions and better consider and control for factors affecting adherence and response to dietary interventions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Dec 2024Dec 2027

First Submitted

Initial submission to the registry

November 22, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

December 9, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

November 22, 2024

Last Update Submit

April 30, 2026

Conditions

Keywords

dietsustainable food choicesfood swapsN of 1 study

Outcome Measures

Primary Outcomes (1)

  • Grams of red meat consumption

    During the first eight weeks (period A1), participants will be instructed to follow their usual diet. From week 9 (period B), participants will start the intervention, where they will receive the food swaps identified and agreed by them during a food swap interview. During the final eight weeks (period A2), participants will cease intervention products. The grams of red meat will be monitored before, during and after the intervention.

    6 months

Secondary Outcomes (6)

  • Weight

    6 months

  • Nutiritional status

    6 months

  • Blood pressure

    6 months

  • Total cholesterol

    6 months

  • Fasting blood glucose

    6 months

  • +1 more secondary outcomes

Study Arms (1)

N of 1 intervention

EXPERIMENTAL

Personalised food swaps and dietary advice on how to incorporate these swaps into the diet

Other: Food Swap

Interventions

Personalised food swaps and dietary advice on how to incorporate these swaps into their usual diet

N of 1 intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • men and women
  • aged 18-30 years,
  • having a high baseline consumption of red meat (More than 70 grams per day or 280 grams per 4 days)
  • who are willing to make their diet healthier and more sustainable but do not know how or are facing barriers

You may not qualify if:

  • Having a lower red meat consumption (less than 70 grams per day or 240 grams per 4 days)
  • being vegetarian or vegan
  • having a clinical diagnosis of hypertension or high cholesterol, having unstable or untreated thyroid disorder
  • taking blood pressure and/or cholesterol-lowering medications (e.g. beta blockers or statins)
  • having food allergies, being on a weight loss diet or having lost \>5kg in the last 6 months
  • having a history of an eating disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rowett Institute, University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

RECRUITING

Study Officials

  • Baukje de Roos, Professor

    UoA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magaly Aceves-Martins, PhD

CONTACT

Baukje de Roos, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This will have an N of 1 design and will not be randomised.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The study will be conducted as a 24-week (\~ 6 months) interventional N-of-1 study with an A1-B-A2 design (8 weeks per study arm). The first A-period represents an observational phase, the B-period represents an intervention phase with personalised food swaps and dietary advice on how to incorporate these swaps into the diet, and the second A-period represents an observational/follow-up period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2024

First Posted

December 3, 2024

Study Start

December 9, 2024

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations