Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

April 4, 2020 updated by: Natalia McInnes, McMaster University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Recruiting
        • McMaster University
        • Contact:
          • Natalia McInnes, MD, MSc
        • Principal Investigator:
          • Natalia McInnes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary intervention 1
Other: 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.
Experimental: Dietary intervention 2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 0 months
Average number of participants recruited per month
0 months
Retention rate in arm 1
Time Frame: 5 months
Percent of enrolled participants who complete the study
5 months
Retention rate in arm 2
Time Frame: 5 months
Percent of enrolled participants who complete the study
5 months
Adherence to the dietary intervention in arm 1
Time Frame: 2 to 5 months
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
2 to 5 months
Adherence to the dietary intervention in arm 2
Time Frame: 2 to 5 months
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
2 to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2020

Primary Completion (Anticipated)

October 15, 2021

Study Completion (Anticipated)

October 15, 2021

Study Registration Dates

First Submitted

January 4, 2020

First Submitted That Met QC Criteria

January 20, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 4, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7992

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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