Evaluation of Food Additive Contributions to Obesity: Pilot Study 1

McMaster University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Obesity (Disorder)

Interventions

Potassium sorbate one-time administration followed by washout then placebo one-time administrationOTHER

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

Placebo one-time administration followed by washout then potassium sorbate one-time administrationOTHER

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

McMaster University Medical Centre

Hamilton, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

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.

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.

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.

Adverse events after randomization

Time frame: From the time of randomization till study completion for each participant, anticipated average of 3 weeks

Central Contacts

Natalia McInnes, MD, MSc

CONTACT

19055212100 natalia.mcinnes@mcmaster.ca

Data from ClinicalTrials.gov

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