Evaluation of Food Additive Contributions to Obesity: Pilot Study 1

ConditionObesity (Disorder)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-80

SponsorMcMaster University

About this trial

The effects of food additives on body weight in humans are largely unknown. This is a pilot cross-over double blind RCT in obese adults aimed to test the feasibility of measuring food consumption over 24 hours after one-time administration of K sorbate versus placebo after participants reduce the background consumption of related food additives.

Eligibility criteria

Qualifiers

Males and females age 20-80; BMI 30-39 kg/m2 inclusive; willingness and ability to follow the proposed study interventions and procedures; informed consent.

Disqualifiers

Weight loss of ≥3% in the last 3 months; previous or planned bariatric surgery in the next 1 year; current or planned participation in any structured weight-loss programs; current or recent (within the last 6 months) use of weight-loss-inducing drugs (including GLP-1 agonists); history of frequent intermittent or continuous use of systemic steroids; excessive alcohol consumption; recent or anticipated adjustments to mood, anxiety or anti-psychotic medications; untreated bipolar disorder or attention deficit hyperactivity disorder; eating disorder or any other disorder that may lead to significant weight changes; breastfeeding, pregnancy, planned pregnancy or planned fatherhood in the next 6 months; type 1 diabetes; uncontrolled diabetes mellitus (HbA1C≥9%); diabetes requiring treatment with insulin; aversion to foods that will be served during testing sessions.

Trial design

Treatments tested in this trial

Potassium sorbate one-time administration followed by washout then placebo one-time administration
Placebo one-time administration followed by washout then potassium sorbate one-time administration

Treatment groups

20 Participants

are divided into 2 treatment groups

Sponsors and collaborators

McMaster University

Lead sponsor

Hamilton Academic Health Sciences Organization

Collaborator

Source ClinicalTrials.gov