Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Other: Dietary intervention

• Registration Number: NCT03758378
• Lead Sponsor: McMaster University

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 with 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-11-12
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-18
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• BMI>/=30 kg/m2
• routine consumption/use of (i) >/=250 ml of artificially-sweetened beverages per day and/or (ii) >/=1 gum per day
• willingness and ability to follow the proposed dietary intervention
• informed consent

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary intervention	Dietary intervention	-

Primary Outcome Measures

Name	Time	Method
Recruitment rate	Baseline
Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls	2 to 4 months	Adherence to the dietary intervention
Retention rate	5 months

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada