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Completed

NCT Number: NCT02035150

Effect of Different Fiber Breakfasts 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oatmeal

Dietary Supplement

A breakfast consisting of oatmeal

Other names: Quaker Quick Oats

Frosted Flakes

Dietary Supplement

A breakfast consisting of Frosted Flakes and milk

Other names: Kelloggs Frosted Flakes

No Breakfast

Dietary Supplement

A breakfast consisting of plain water

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

New York Obesity and Nutrition Research Center

Other

Collaborators

  • PepsiCo Global R&D

Registry information

Official study title

The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects

Important dates

Study start
1998
Primary completion
2000
Study completion
2002
First posted
Jan 14, 2014
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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