Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

McMaster University

Status

Unknown

Conditions

Obesity

Treatments

Other: Dietary intervention 2

Other: Dietary intervention 1

Study type

Interventional

Funder types

Other

Identifiers

NCT04236713

7992

Details and patient eligibility

About

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.

Enrollment

10 estimated 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 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