Clinical trial NCT02035150: Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects
Official title: The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: breakfast
oatmeal
appetite
cholesterol
Lead sponsor: New York Obesity and Nutrition Research Center
Sponsor class: OTHER
Collaborators: name: PepsiCo Global R&D
First posted: 2014-01-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Regular breakfast consumption may help lower body weight reduce body fatness and improve cardiovascular disease risk factors. However, the best kind of breakfast to consume to achieve these effects is unclear. We hypothesized that a high fiber breakfast would suppress appetite, lower body weight and improve cardiovascular disease risk factors compared with a no-fiber breakfast.

Detailed description: Participants will report to the hospital cafeteria between 0800 and 0900h following an overnight fast every weekday for 4 consecutive weeks. On arrival, participants will be provided will the allocated breakfast and will be given 15 min to consume all the foods provided. The oatmeal breakfast will consist of 80g dry oatmeal (Quaker Quick Oats) prepared with 120mL fat-free milk and 230mL water. The frosted flakes breakfast will consist of 62g frosted flakes and 160mL whole milk and 190mL water served on the side. The No-breakfast (control) will consist of only 350mL plain water. All participants will also receive 200mL decaffeinated coffee with 12mL non-dairy creamer and 1g packet of non-caloric sweetener. On Friday of each week participants will be provided with two portions of the breakfasts to take home at consume on the weekend days. On the first day of the intervention and weekly thereafter participants will complete 3hr subjective appetite ratings responses to the breakfast. Laboratory assessments including body weight, composition, blood pressure and a fasting blood sample will be collected before the start of the intervention and at the end of the intervention.

Eligibility criteria: Inclusion Criteria:

* BMI \>27kg/m2
* Weight stable (\<5% weight change in past 3 months)

Exclusion Criteria:

* Smokers
* Regular use of medications
* Currently undertaking a weight-loss or exercise program
* Females who are pregnant or lactating

Primary outcomes:
measure: Change in body weight
timeFrame: Change in body weight over 4 week intervention
Secondary outcomes:
measure: Subjective appetite
timeFrame: Appetite ratings in response to breakfast will be collected for 3hs on the first day of the study and after 1, 2, 3 and 4 weeks of the intervention
measure: Change in plasma metabolic risk factors
timeFrame: At baseline and following 4-week intervention
measure: Resting Energy Expenditure
timeFrame: Resting energy expenditure will be measured at baseline and following the 4 week intervention
Other outcomes:
measure: Blood pressure
timeFrame: At baseline and following 4-week intervention
Locations:
Study officials:
affiliation: New York Obesity Nutrition Research Center
name: Allan Geliebter, PhD
role: PRINCIPAL_INVESTIGATOR
References: