Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2

NCT03758378 | Terminated

• 1 other identifier: 5311
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

dietary modification

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Baseline

• Retention rate

  5 months

• Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls

  Adherence to the dietary intervention

  2 to 4 months

Study Arms (1)

Dietary intervention

EXPERIMENTAL

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Limiting dietary exposure to high intensity sweeteners and sugar alcohols; limiting eating out to a maximum of 2 days per week.

Dietary intervention

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 29, 2018
• Study Start: November 12, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)