Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

Obesity Clinical Trial

Official title:

Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03758378
• Other study ID #: 5311
• Status: Terminated
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: August 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Dietary intervention
Limiting dietary exposure to high intensity sweeteners and sugar alcohols; limiting eating out to a maximum of 2 days per week.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate		Baseline
Primary	Retention rate		5 months
Primary	Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls	Adherence to the dietary intervention	2 to 4 months