NCT02035150

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 1998

Longer than P75 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
11.1 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

January 8, 2014

Last Update Submit

January 10, 2014

Conditions

Keywords

breakfastoatmealappetitecholesterol

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • Change in plasma metabolic risk factors

    At baseline and following 4-week intervention

  • Resting Energy Expenditure

    Resting energy expenditure will be measured at baseline and following the 4 week intervention

Other Outcomes (1)

  • Blood pressure

    At baseline and following 4-week intervention

Study Arms (3)

Oatmeal Breakfast

EXPERIMENTAL

Participants will consume oatmeal breakfast daily for 4 weeks

Dietary Supplement: Oatmeal

Frosted Flakes

EXPERIMENTAL

Participants will consume a frosted flakes breakfast daily for 4-weeks

Dietary Supplement: Frosted Flakes

No Breakfast

PLACEBO COMPARATOR

Participants will consume no breakfast for a 4-week period

Dietary Supplement: No Breakfast

Interventions

OatmealDIETARY_SUPPLEMENT

A breakfast consisting of oatmeal

Also known as: Quaker Quick Oats
Oatmeal Breakfast
Frosted FlakesDIETARY_SUPPLEMENT

A breakfast consisting of Frosted Flakes and milk

Also known as: Kelloggs Frosted Flakes
Frosted Flakes
No BreakfastDIETARY_SUPPLEMENT

A breakfast consisting of plain water

No Breakfast

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>27kg/m2
  • Weight stable (\<5% weight change in past 3 months)

You may not qualify if:

  • Smokers
  • Regular use of medications
  • Currently undertaking a weight-loss or exercise program
  • Females who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Allan Geliebter, PhD

    New York Obesity Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 14, 2014

Study Start

March 1, 1998

Primary Completion

February 1, 2000

Study Completion

December 1, 2002

Last Updated

January 14, 2014

Record last verified: 2014-01