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
15 weeks
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
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.
CONDITIONS
Official 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 year
- Current or planned participation in any structured weight-loss programs
- Current or recent (within 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 changes to mood, anxiety, or anti-psychotic 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 in the next 6 months
- Type 1 diabetes
- Uncontrolled diabetes mellitus (HbA1C 9% or higher)
- Diabetes requiring treatment with insulin
- Aversion to foods served during testing sessions
AI-Screening
AI-Powered Screening
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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
CONTACT
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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