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

Obesity Clinical Trial

Official title:

The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035150
• Other study ID #: 98-022
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: January 10, 2014
• Start date: March 1998
• Est. completion date: December 2002

Study information

• Verified date: January 2014
• Source: New York Obesity and Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2002
• Est. primary completion date: February 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Body Weight Changes
• Obesity

Intervention

Dietary Supplement:
• Oatmeal
A breakfast consisting of oatmeal
• Frosted Flakes
A breakfast consisting of Frosted Flakes and milk
• No Breakfast
A breakfast consisting of plain water

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York Obesity and Nutrition Research Center	PepsiCo Global R&D

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure	Systolic and diastolic blood pressure will be measured at baseline and following 4-week intervention	At baseline and following 4-week intervention	No
Primary	Change in body weight	Body weight will be measured at baseline and following 4-week breakfast intervention	Change in body weight over 4 week intervention	No
Secondary	Subjective appetite	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.	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	No
Secondary	Change in plasma metabolic risk factors	A fasting blood sample will be collected and analyzed for glucose, insulin, triacylglycerol, leptin and cholesterol	At baseline and following 4-week intervention	No
Secondary	Resting Energy Expenditure	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.	Resting energy expenditure will be measured at baseline and following the 4 week intervention	No