Evaluation of Food Additive Contributions to Obesity: Pilot Study 1
ConditionObesity (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Potassium sorbate one-time administration followed by washout then placebo one-time administration
Other interventionK 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
Placebo one-time administration followed by washout then potassium sorbate one-time administration
Other interventionPlacebo 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
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: K sorbate one-time administration followed by washout then placebo one-time administrationExperimental treatment 1 intervention
Group B: Placebo one-time administration followed by washout then K sorbate one-time administrationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Time frame
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.2
Randomization rate
Time frame
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.3
Retention rate at the study end
Percentage of randomized participants who complete 2 testing sessions after randomization
Time frame
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.4
Adherence to the proposed dietary modifications on 24-hour dietary recalls conducted at or after randomization
Time frame
From randomization till the end of the second testing session for each participant, anticipated average of 2 weeks.Sponsors and contacts
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McMaster University
Lead sponsor
Hamilton Academic Health Sciences Organization
Collaborator
Source ClinicalTrials.gov