Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

Not Applicable

• Conditions: Obesity
• Interventions: Other: Dietary intervention 2; Other: Dietary intervention 1

• Registration Number: NCT04236713
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-04
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-22
• Study Start: 2020-01-24
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-04
• Last Update Posted: 2020-04-07
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary intervention 2	Dietary intervention 2	-
Dietary intervention 1	Dietary intervention 1	-

Primary Outcome Measures

Name	Time	Method
Retention rate in arm 2	5 months	Percent of enrolled participants who complete the study
Recruitment rate	0 months	Average number of participants recruited per month
Adherence to the dietary intervention in arm 1	2 to 5 months	Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Adherence to the dietary intervention in arm 2	2 to 5 months	Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Retention rate in arm 1	5 months	Percent of enrolled participants who complete the study

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada