Evaluation of Food Additive Contributions to Obesity: Pilot Study 1
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
| Condition(s) | Obesity (Disorder) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 signifi |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Lead sponsor | McMaster University |
| Locations | Hamilton, Ontario, Canada |
| Start date | 2026-02-10 |
| NCT ID | NCT07437430 |
| Official listing | https://clinicaltrials.gov/study/NCT07437430 |