Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1

McMaster University

Status: Completed

Conditions: Obesity

Treatments: Other: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03757962

5157

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Dietary intervention

Experimental group

Treatment:

Other: Dietary intervention