Dietary Intervention Study on Food Based Dietary Guidelines for Sustainable and Healthy Lifestyles

NCT ID: NCT05253547

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2023-06-01

Brief Summary

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The aim of the study is to provide proof of the effectiveness, acceptability, healthfulness and nutritional adequacy of dietary guidelines to reduce greenhouse gas emissions. The study will compare the effect of dietary advice based on 1) healthy climate-friendly dietary guidelines (intervention group) or 2) standard healthy dietary guidelines (control) on greenhouse gas emissions associated with dietary intake over 12 weeks.

Detailed Description

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A randomised, parallel controlled trial will recruit n=360 healthy adults (age 18-64) across three research centres. After successful screening and receiving informed consent, participants will be randomised into the intervention or the control group for the duration of the 12-week trial described in detail in the text and figure below. The intervention group will receive dietary advice based on climate friendly eating recommendations. The control group will receive dietary recommendations based on Healthy Ireland's Healthy Eating Guidelines and Food Pyramid (FSAI, 2019).

Prior to their first onsite visit, participants will be asked to complete a Health and Lifestyle questionnaire and dietary assessment. The dietary assessment will include

1. 3 online 24-hour recalls (2 non-consecutive weekdays and 1 weekend day) (via web-based dietary recall tool, Foodbook24)
2. a food frequency questionnaire (Foodbook24)

Baseline, Visit 1 (Week 0): We will collect blood and urine samples from participants and record anthropometric measurements. Participants will be asked to complete a Stage of Change questionnaire to assess their openness to a diet change. All participants will complete a Food Waste Questionnaire at baseline for later comparison at endpoint. At the end of Visit 1 participants will receive a personalised feedback report and advice from nutritionists based on their habitual diet.

Week 6: Participants will be asked to complete a second dietary assessment during week 6. 3 24-hour recalls and a food frequency questionnaire will be hosted on Foodbook24, a web-based dietary recall tool.

Week 11: Before attending endpoint onsite visit, participants will complete a final dietary assessment. The same assessment as Pre-baseline and Week 6 will be used.

Endpoint, Visit 2 (Week 12): At the end of 12 weeks, participants will be invited back for a follow-up assessment. Blood and urine samples and anthropometrics will be collected/recorded. Participants will complete the Stage of Change questionnaire and Food Waste questionnaire. A Tolerance questionnaire will be administered to see how willing participants would be to continue with their prescribed diet.

Conditions

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Dietary Habits Healthy Diet Healthy Nutrition Personalized Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel randomized control trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Single-blinded parallel study

Study Groups

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Healthy climate-friendly dietary guidelines

Personalised healthy dietary recommendations aimed at reducing diet-related greenhouse gas emissions

Group Type EXPERIMENTAL

Healthy climate-friendly dietary guidelines

Intervention Type BEHAVIORAL

Personalised climate-friendly healthy dietary recommendations

Healthy eating guidelines

Personalised healthy dietary recommendations based on Ireland's Healthy Eating Guidelines

Group Type ACTIVE_COMPARATOR

Healthy dietary guidelines

Intervention Type BEHAVIORAL

Personalised healthy dietary recommendations

Interventions

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Healthy climate-friendly dietary guidelines

Personalised climate-friendly healthy dietary recommendations

Intervention Type BEHAVIORAL

Healthy dietary guidelines

Personalised healthy dietary recommendations

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Provide written informed consent
* Be a healthy adult between the ages of 18-64 years old
* Consume a diet associated with moderate-high greenhouse gas emissions
* Be in good general health

Exclusion Criteria

* Are pregnant, lactating or planning to become pregnant
* Are following a medically prescribed diet
* Have a diagnosis of an acute or chronic medical condition that could interfere with the outcomes of the study. Such diagnoses include (but are not limited to) cardiovascular disease, diabetes mellitus, inflammatory bowel disease, cancers (within the last 5 years), etc.
* Are immunocompromised or have a suspected immunodeficiency
* Have excessive alcohol intake (\>28 units per week)
* Have a known food allergy
* Regularly consume a single high-dose vitamin or mineral supplement
* Are participating in another research study
* Are unable to read, write or understand English.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Teagasc

INDUSTRY

Sponsor Role collaborator

University College Cork

OTHER

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Aifric O'Sullivan

Lecturer/Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aifric O'Sullivan, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Locations

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University College Cork

Cork, , Ireland

Site Status

University College Dublin

Dublin, , Ireland

Site Status

Queen's University Belfast

Belfast, , United Kingdom

Site Status

Countries

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Ireland United Kingdom

References

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Davies KP, Gibney ER, Leonard UM, Lindberg L, Woodside JV, Kiely ME, Nugent AP, Arranz E, Conway MC, McCarthy SN, O'Sullivan AM. Sustainable diets reduce diet-related greenhouse gas emissions and improve diet quality: results from the MyPlanetDiet randomized controlled trial. Am J Clin Nutr. 2025 Oct;122(4):962-971. doi: 10.1016/j.ajcnut.2025.05.015. Epub 2025 Aug 26.

Reference Type DERIVED
PMID: 41043876 (View on PubMed)

Leonard UM, Davies KP, Lindberg L, Woodside JV, Nugent AP, O'Sullivan AM, Gibney ER, McCarthy SN, Arranz E, Kiely ME. Impact of sustainable diets on micronutrient intakes and status: outcomes of the MyPlanetDiet randomized controlled trial. Am J Clin Nutr. 2025 Sep 8:S0002-9165(25)00525-8. doi: 10.1016/j.ajcnut.2025.09.009. Online ahead of print.

Reference Type DERIVED
PMID: 40930463 (View on PubMed)

Davies KP, Gibney ER, Leonard UM, Lindberg L, Woodside JV, Kiely ME, Nugent AP, Arranz E, Conway MC, McCarthy SN, O'Sullivan AM. Developing and testing personalised nutrition feedback for more sustainable healthy diets: the MyPlanetDiet randomised controlled trial protocol. Eur J Nutr. 2024 Oct;63(7):2681-2696. doi: 10.1007/s00394-024-03457-0. Epub 2024 Jul 6.

Reference Type DERIVED
PMID: 38970665 (View on PubMed)

Other Identifiers

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LS-21-51-Davies-OSullivan

Identifier Type: -

Identifier Source: org_study_id

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