Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Frosted Flakes; Dietary Supplement: No Breakfast; Dietary Supplement: Oatmeal

• Registration Number: NCT02035150
• Lead Sponsor: New York Obesity and Nutrition Research Center

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.

Study Timeline

• Study Start: 1998-03
• Primary Completion: 2000-02
• Study Completion: 2002-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-10
• Last Update Submitted: 2014-01-10
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frosted Flakes	Frosted Flakes	Participants will consume a frosted flakes breakfast daily for 4-weeks
No Breakfast	No Breakfast	Participants will consume no breakfast for a 4-week period
Oatmeal Breakfast	Oatmeal	Participants will consume oatmeal breakfast daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in body weight	Change in body weight over 4 week intervention	Body weight will be measured at baseline and following 4-week breakfast intervention

Secondary Outcome Measures

Name	Time	Method
Subjective appetite	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	Ratings of hunger and Fullness will be collected on a 6 point rating scale with 0 labelled not at all, 40 moderately, 60 quite, 80 very and 100 extremely.
Change in plasma metabolic risk factors	At baseline and following 4-week intervention	A fasting blood sample will be collected and analyzed for glucose, insulin, triacylglycerol, leptin and cholesterol
Resting Energy Expenditure	Resting energy expenditure will be measured at baseline and following the 4 week intervention	Resting energy expenditure measurements will be collected whilst subjects are fasting, resting in a semi-supine position under thermoneutral conditions with a ventilated hood and metabolic cart.