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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

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.

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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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035150


Sponsors and Collaborators
New York Obesity and Nutrition Research Center
PepsiCo Global R&D
Investigators
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Principal Investigator: Allan Geliebter, PhD New York Obesity Nutrition Research Center
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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    Key Record Dates
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:
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Overweight
Body Weight Changes
Body Weight