Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

NCT ID: NCT04236713

Last Updated: 2020-04-07

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2021-10-15

Brief Summary

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The effects of food additives on body weight in humans are largely unknown. This is a feasibility study in 10 obese adults who will be followed for 5 months. Eligible participants will be non-randomly assigned to 2 groups and will be taught how to limit the exposure to the studied food additives in their diet. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dietary intervention 1

Group Type EXPERIMENTAL

Dietary intervention 1

Intervention Type OTHER

Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week.

Dietary intervention 2

Group Type EXPERIMENTAL

Dietary intervention 2

Intervention Type OTHER

Limiting dietary exposure to nitrites, sulfites and related food additives; limiting eating out to a maximum of 2 days per week; limiting drinking wine to a maximum of 2 days per week.

Interventions

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Dietary intervention 1

Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week.

Intervention Type OTHER

Dietary intervention 2

Limiting dietary exposure to nitrites, sulfites and related food additives; limiting eating out to a maximum of 2 days per week; limiting drinking wine to a maximum of 2 days per week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI \>/=30 kg/m2
* willingness and ability to follow the proposed dietary interventions
* informed consent

Exclusion Criteria

* previous or planned bariatric surgery in the next 1 year
* current or planned participation in any structured weight-loss programs in the next 6 months
* current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
* excessive alcohol consumption
* bipolar disorder or attention deficit hyperactivity disorder
* current use of anti-depressant or anti-psychotic medications
* eating disorder or any other active disorder that may lead to significant weight changes
* pregnancy or planned pregnancy in the next 1 year
* uncontrolled diabetes mellitus or diabetes requiring treatment with \>2 oral diabetes medications or with insulin
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Natalia McInnes

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Natalia McInnes

Role: CONTACT

905-521-2100 ext. 73794

Facility Contacts

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Natalia McInnes, MD, MSc

Role: primary

Other Identifiers

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7992

Identifier Type: -

Identifier Source: org_study_id

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