Evaluation of Food Additive Contributions to Obesity: Pilot Study 1
McMaster University
20 participants
Feb 10, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria1
- 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.
Exclusion Criteria1
- 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.
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Interventions
K sorbate 450 mg will be administered with breakfast during testing session 1, followed by a minimum of 2-week washout and then placebo administration with breakfast during testing session 2
Placebo will be administered with breakfast during testing session 1, followed by a minimum of 2-week washout and then K sorbate 450 mg administration with breakfast during testing session 2
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07437430