Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

• Sponsor: McMaster University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03758378
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants with meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Dietary intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2
• Actual Study Start Date: Nov 12, 2018
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dietary intervention	Other: Dietary intervention; Limiting dietary exposure to high intensity sweeteners and sugar alcohols; limiting eating out to a maximum of 2 days per week.

Outcome Measures

Primary Outcome Measures

1. Recruitment rate [Baseline]

2. Retention rate [5 months]

3. Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls [2 to 4 months]

   Adherence to the dietary intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• BMI>/=30 kg/m2

• routine consumption/use of (i) >/=250 ml of artificially-sweetened beverages per day and/or (ii) >/=1 gum per day

• willingness and ability to follow the proposed dietary intervention

• informed consent

Exclusion Criteria:

• previous or planned bariatric surgery in the next 1 year

• current or planned participation in any structured weight-loss programs in the next 6 months

• current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids

• bipolar disorder or attention deficit hyperactivity disorder

• current use of anti-depressant or anti-psychotic medications

• eating disorder or any other active disorder that may lead to significant weight changes

• working night shifts

• pregnancy or planned pregnancy in the next 1 year

• uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster University	Hamilton	Ontario	Canada	L8S 4K1

Sponsors and Collaborators

• McMaster University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Natalia McInnes, Associate Professor, McMaster University
• ClinicalTrials.gov Identifier: NCT03758378
• Other Study ID Numbers: 5311
• First Posted: Nov 29, 2018
• Last Update Posted: Aug 20, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Natalia McInnes, Associate Professor, McMaster University: dietary modification
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Aug 20, 2019