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

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

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE January 14, 2014
Last Update Posted Date January 14, 2014
Study Start Date  ICMJE March 1998
Actual Primary Completion Date February 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects
Official Title  ICMJE The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Oatmeal
    A breakfast consisting of oatmeal
    Other Name: Quaker Quick Oats
  • Dietary Supplement: Frosted Flakes
    A breakfast consisting of Frosted Flakes and milk
    Other Name: Kelloggs Frosted Flakes
  • Dietary Supplement: No Breakfast
    A breakfast consisting of plain water
Study Arms  ICMJE
  • Experimental: Oatmeal Breakfast
    Participants will consume oatmeal breakfast daily for 4 weeks
    Intervention: Dietary Supplement: Oatmeal
  • Experimental: Frosted Flakes
    Participants will consume a frosted flakes breakfast daily for 4-weeks
    Intervention: Dietary Supplement: Frosted Flakes
  • Placebo Comparator: No Breakfast
    Participants will consume no breakfast for a 4-week period
    Intervention: Dietary Supplement: No Breakfast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2002
Actual Primary Completion Date February 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02035150
Other Study ID Numbers  ICMJE 98-022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
Study Sponsor  ICMJE New York Obesity and Nutrition Research Center
Collaborators  ICMJE PepsiCo Global R&D
Investigators  ICMJE
Principal Investigator: Allan Geliebter, PhD New York Obesity Nutrition Research Center
PRS Account New York Obesity and Nutrition Research Center
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP