Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

Last updated: April 4, 2020
Sponsor: McMaster University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04236713
7992
  • Ages 20-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BMI >/=30 kg/m2

  • willingness and ability to follow the proposed dietary interventions

  • informed consent

Exclusion

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 6months

  • current or recent (within the last 6 months) use of weight-loss-inducing drugs orsystemic 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 weightchanges

  • pregnancy or planned pregnancy in the next 1 year

  • uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetesmedications or with insulin

Study Design

Total Participants: 10
Study Start date:
January 24, 2020
Estimated Completion Date:
October 15, 2021

Connect with a study center

  • McMaster University

    Hamilton, Ontario L8S 4K1
    Canada

    Active - Recruiting

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