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Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03757962
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Natalia McInnes, McMaster University

Study Description
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Brief Summary:
The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants will meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.

Condition or disease Intervention/treatment Phase
Obesity Other: Dietary intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1
Actual Study Start Date : November 13, 2018
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dietary intervention Other: Dietary intervention
Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 0 months ]
  2. Retention rate [ Time Frame: 5 months ]
  3. Adherence to the dietary intervention [ Time Frame: 2 to 4 months ]
    Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls conducted at 2, 3 and 4 months


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI>/=30 kg/m2
  • willingness and ability to follow the proposed dietary intervention
  • 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
  • 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
  • working night shifts
  • pregnancy or planned pregnancy in the next 1 year
  • uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757962


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
More Information
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Responsible Party: Natalia McInnes, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03757962    
Other Study ID Numbers: 5157
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natalia McInnes, McMaster University:
dietary modification
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight