Obesity (Disorder)
Conditions
Brief 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.
Interventions
OTHERPotassium sorbate one-time administration followed by washout then placebo one-time administration
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
OTHERPlacebo one-time administration followed by washout then potassium sorbate one-time administration
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
Sponsors
McMaster University
Hamilton Academic Health Sciences Organization
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Through active recruitment period (from the start of the recruitment period to the date the last participant could still be recruited into the study), anticipated to be 6 weeks. | — |
| Randomization rate | Through active trial conduction period (from the first participant first study visit to the last conducted study visit in the whole study), anticipated to be 15 weeks. | — |
| Retention rate at the study end | Through active trial conduction period (from the first participant first study visit to the last conducted study visit in the whole study), anticipated to be 15 weeks. | Percentage of randomized participants who complete 2 testing sessions after randomization |
| Adherence to the proposed dietary modifications on 24-hour dietary recalls conducted at or after randomization | From randomization till the end of the second testing session for each participant, anticipated average of 2 weeks. | — |
| Adverse events after randomization | From the time of randomization till study completion for each participant, anticipated average of 3 weeks | — |
Countries
Canada
Contacts
CONTACTNatalia McInnes, MD, MSc
Outcome results
None listed