ObesityNCT02035150
Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects
A study testing Oatmeal, Frosted Flakes and No Breakfast in people with Obesity, run by New York Obesity and Nutrition Research Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Oatmeal, Frosted Flakes and No Breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 1998to Dec 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >27kg/m2
- Weight stable (<5% weight change in past 3 months)
Who cannot join
- Smokers
- Regular use of medications
- Currently undertaking a weight-loss or exercise program
- Females who are pregnant or lactating
About this study
Official title: The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Oatmeal, Frosted Flakes, No Breakfast
- Keywords
- breakfast, oatmeal, appetite, cholesterol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OatmealDietary supplement
Also called Quaker Quick Oats
A breakfast consisting of oatmeal
Frosted FlakesDietary supplement
Also called Kelloggs Frosted Flakes
A breakfast consisting of Frosted Flakes and milk
No BreakfastDietary supplement
A breakfast consisting of plain water
| Study group | Role | What they receive |
|---|---|---|
| Oatmeal Breakfast | Experimental | Participants will consume oatmeal breakfast daily for 4 weeks Receives: Dietary Supplement: Oatmeal |
| Frosted Flakes | Experimental | Participants will consume a frosted flakes breakfast daily for 4-weeks Receives: Dietary Supplement: Frosted Flakes |
| No Breakfast | Placebo comparator | Participants will consume no breakfast for a 4-week period Receives: Dietary Supplement: No Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Body weight will be measured at baseline and following 4-week breakfast intervention
Measured: Change in body weight over 4 week intervention
Secondary outcomes (3)
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.
Measured: 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
A fasting blood sample will be collected and analyzed for glucose, insulin, triacylglycerol, leptin and cholesterol
Measured: At baseline and following 4-week intervention
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.
Measured: Resting energy expenditure will be measured at baseline and following the 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startMar 1998
- Primary completionFeb 2000
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Obesity and Nutrition Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- PepsiCo Global R&D
- Responsible party
- Principal investigator, Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
- Investigators
- Allan Geliebter, PhD, Principal investigator, New York Obesity Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035150
- Sponsor's protocol ID
- 98-022
- Status last verified
- Jan 2014
- First submitted
- 8 Jan 2014
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects
- ClinicalTrials.gov ID
- NCT02035150
- Acronym / sponsor ID
- 98-022
- Conditions
- Obesity
- Keywords
- breakfast, oatmeal, appetite, cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- New York Obesity and Nutrition Research CenterUniversity, hospital or other
- Collaborators
- PepsiCo Global R&D
- Study start
- Mar 1998
- Primary completion
- Feb 2000 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oatmeal Breakfast | Experimental | Dietary Supplement: OatmealParticipants will consume oatmeal breakfast daily for 4 weeks |
| Frosted Flakes | Experimental | Dietary Supplement: Frosted FlakesParticipants will consume a frosted flakes breakfast daily for 4-weeks |
| No Breakfast | Placebo comparator | Dietary Supplement: No BreakfastParticipants will consume no breakfast for a 4-week period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >27kg/m2
- Weight stable (<5% weight change in past 3 months)
Key exclusion criteria (4 listed)
- Smokers
- Regular use of medications
- Currently undertaking a weight-loss or exercise program
- Females who are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OatmealAlso: Quaker Quick OatsA breakfast consisting of oatmeal | Dietary supplement | Oatmeal Breakfast |
| Frosted FlakesAlso: Kelloggs Frosted FlakesA breakfast consisting of Frosted Flakes and milk | Dietary supplement | Frosted Flakes |
| No BreakfastA breakfast consisting of plain water | Dietary supplement | No Breakfast |
Primary outcome
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
3 secondary outcomes
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
Change in plasma metabolic risk factors
Time frame: At baseline and following 4-week intervention
Resting Energy Expenditure
Time frame: Resting energy expenditure will be measured at baseline and following the 4 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Geliebter, PhD principal investigator
New York Obesity Nutrition Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Oatmeal, Frosted Flakes and No Breakfast in people with Obesity, run by New York Obesity and Nutrition Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Change in body weight over 4 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.