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Completed

NCT Number: NCT03757962

Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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