Evaluation of Food Additive Contributions to Obesity: Pilot Study 1
Recruiting · NCT07437430 · Interventional (participants receive a specific treatment) · Lead sponsor: McMaster University
View the official record on ClinicalTrials.gov →Interventions studied
Placebo one-time administration followed by washout then potassium sorbate one-time administrationPotassium sorbate one-time administration followed by washout then placebo one-time administration
What this trial is about
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.
Who can take part
Age range
20 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- McMaster University Medical Centre - Hamilton, Ontario, Canada