Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03757962

Enrollment

Registered

2018-11-29

Start date

2018-11-13

Completion date

2019-07-16

Last updated

2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

dietary modification

Brief summary

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.

Interventions

OTHERDietary intervention

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Recruitment rate	0 months	—
Retention rate	5 months	—
Adherence to the dietary intervention	2 to 4 months	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026