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

• ClinicalTrials.gov Identifier: NCT02035150
• Recruitment Status: Completed
• First Posted: January 14, 2014
• Last Update Posted: January 14, 2014
• Sponsor: New York Obesity and Nutrition Research Center
• Collaborator: PepsiCo Global R&D
• Information provided by (Responsible Party): Dr. Allan Geliebter, New York Obesity and Nutrition Research Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Dietary Supplement: Oatmeal; Dietary Supplement: Frosted Flakes; Dietary Supplement: No Breakfast	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects
• Study Start Date: March 1998
• Actual Primary Completion Date: February 2000
• Actual Study Completion Date: December 2002

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oatmeal Breakfast; Participants will consume oatmeal breakfast daily for 4 weeks	Dietary Supplement: Oatmeal; A breakfast consisting of oatmeal; Other Name: Quaker Quick Oats
Experimental: Frosted Flakes; Participants will consume a frosted flakes breakfast daily for 4-weeks	Dietary Supplement: Frosted Flakes; A breakfast consisting of Frosted Flakes and milk; Other Name: Kelloggs Frosted Flakes
Placebo Comparator: No Breakfast; Participants will consume no breakfast for a 4-week period	Dietary Supplement: No Breakfast; A breakfast consisting of plain water

Outcome Measures

Primary Outcome Measures :

1. Change in body weight [ Time Frame: Change in body weight over 4 week intervention ]
   Body weight will be measured at baseline and following 4-week breakfast intervention

Secondary Outcome Measures :

1. Subjective appetite [ Time Frame: 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.
2. Change in plasma metabolic risk factors [ Time Frame: At baseline and following 4-week intervention ]
   A fasting blood sample will be collected and analyzed for glucose, insulin, triacylglycerol, leptin and cholesterol
3. Resting Energy Expenditure [ Time Frame: 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.

Other Outcome Measures:

1. Blood pressure [ Time Frame: At baseline and following 4-week intervention ]
   Systolic and diastolic blood pressure will be measured at baseline and following 4-week intervention

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Sponsors and Collaborators

New York Obesity and Nutrition Research Center

PepsiCo Global R&D

Investigators

• Principal Investigator: Allan Geliebter, PhD; New York Obesity Nutrition Research Center

More Information

• Responsible Party: Dr. Allan Geliebter, Research Scientist, New York Obesity and Nutrition Research Center
• ClinicalTrials.gov Identifier: NCT02035150
• Other Study ID Numbers: 98-022
• First Posted: January 14, 2014
• Last Update Posted: January 14, 2014
• Last Verified: January 2014

Keywords provided by Dr. Allan Geliebter, New York Obesity and Nutrition Research Center:

breakfast; oatmeal; appetite; cholesterol

Additional relevant MeSH terms:

Overweight; Body Weight Changes; Body Weight