Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

Obesity Clinical Trial

Official title:

Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04236713
• Other study ID #: 7992
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: April 2020
• Source: McMaster University
• Contact: Natalia McInnes
• Phone: 905-521-2100
• Email: natalia.mcinnes[@]mcmaster.ca
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• BMI >/=30 kg/m2

• willingness and ability to follow the proposed dietary interventions

• 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

• 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 weight changes

• 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 1
Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week.
• Dietary intervention 2
Limiting dietary exposure to nitrites, sulfites and related food additives; limiting eating out to a maximum of 2 days per week; limiting drinking wine 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	Average number of participants recruited per month	0 months
Primary	Retention rate in arm 1	Percent of enrolled participants who complete the study	5 months
Primary	Retention rate in arm 2	Percent of enrolled participants who complete the study	5 months
Primary	Adherence to the dietary intervention in arm 1	Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls	2 to 5 months
Primary	Adherence to the dietary intervention in arm 2	Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls	2 to 5 months