Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1

McMaster University6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Dietary interventionOTHER

Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

McMaster University

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Recruitment rate

Time frame: 0 months

Retention rate

Time frame: 5 months

Adherence to the dietary intervention

Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls conducted at 2, 3 and 4 months

Time frame: 2 to 4 months

Data from ClinicalTrials.gov

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