Actively Recruiting
Evaluation of Food Additive Contributions to Obesity: Pilot Study 1
Led by McMaster University · Updated on 2026-02-27
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
H
Hamilton Academic Health Sciences Organization
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how certain food additives might affect body weight in adults with obesity. This pilot randomized controlled trial aims to test the feasibility of measuring food consumption over 24 hours after a single administration of potassium sorbate compared to a placebo. Participants will first reduce their intake of related food additives to better observe any effects. The study involves two testing sessions where participants receive either a one-time 450 mg dose of potassium sorbate with breakfast followed by a washout period and then a placebo dose, or vice versa. Each washout period lasts at least two weeks between sessions. This crossover design allows participants to serve as their own controls. Participants will be monitored for recruitment, randomization, and retention rates during the 15-week active trial period. Dietary adherence is assessed through 24-hour dietary recalls for about two weeks after randomization. Researchers will also track any adverse events from randomization until study completion. The study is expected to end by June 2026.
CONDITIONS
Brief Title
Evaluation of Food Additive Contributions to Obesity: Pilot Study 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 20 to 80 years
- Body mass index (BMI) between 30 and 39 kg/m2 inclusive
- Willingness and ability to follow the proposed study interventions and procedures
- Ability to provide informed consent
You will not qualify if you...
- Weight loss of 3% or more in the last 3 months
- Previous or planned bariatric surgery within the next 1 year
- Current or planned participation in any structured weight-loss programs
- Current or recent (within 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 changes to mood, anxiety, or antipsychotic medications
- Untreated bipolar disorder or attention deficit hyperactivity disorder
- Eating disorder or any other disorder that may cause significant weight changes
- Breastfeeding, pregnancy, planned pregnancy, or planned fatherhood within the next 6 months
- Type 1 diabetes
- Uncontrolled diabetes mellitus (HbA1C ≥ 9%)
- Diabetes requiring insulin treatment
- Aversion to foods served during testing sessions
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 weeks including washout
Participants receive one-time administration of potassium sorbate or placebo with breakfast during testing sessions separated by a minimum 2-week washout period.
2 testing sessions (in-person) separated by at least 2 weeks
Duration - Up to 3 weeks after the second testing session
Participants are observed for adverse events and adherence to dietary modifications after randomization until study completion.
Visits as needed for monitoring
Trial Site Locations
Total: 1 location
1
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8S 4K1
Actively Recruiting
Research Team
N
Natalia McInnes, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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