- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03490851
The Effect of a Breakfast Meal Containing Oat β-glucan on Food Intake at a Subsequent Meal in Normal-weight and Overweight Subjects
November 27, 2019 updated by: PepsiCo Global R&D
The Effect of a Breakfast Meal Containing Oat β-glucan on Food Intake at a Subsequent Meal in Normal-weight and Overweight Subjects: A Randomized, Placebo-controlled Cross-over Study
The objectives of this study are to determine, in normal-weight and overweight subjects the effect of: Primary: oatmeal containing 4 g oat β-glucan on food intake at a subsequent meal compared to Cream of Rice cereal.
Secondary: (i) oatmeal containing 2 g oat β-glucan on food intake at a subsequent meal compared to Cream of Rice cereal; and (ii) oatmeal containing 2g, 4g and 4g low MW oat beta-glucan on subjective appetite ratings, gastric emptying, postprandial responses of glucose, insulin, ghrelin and PYY levels compared to those elicited by Cream of Rice cereal.
In addition, the relationship between amount, MW and viscosity of OBG and the primary and secondary objectives will be determined.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Toronto, Canada
- Glycemic Index Laboratories
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non-smoking male or non-pregnant, non-lactating females, 18-60 years of age, inclusive.
- Subject is not currently participating nor recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement or lifestyle modification. Subject has not participated in another trial involving measurement of postprandial glucose response within 5 days of any of the 4 test visits in this study.
- Body mass index (BMI) ≥ 20.0 and < 30.0 kg/m² at screening.
- Unrestrained eater (<11)
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before study days and during study days.
- Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
- Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
- Hemoglobin ≥120g/L for females or ≥130g/L for males.
- Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
- Failure to meet any one of the inclusion criteria.
- Smokers
- Hemoglobin measurements of <120g/L for females and <130g/L for males (as per WHO criteria for anemia)
- Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- Known intolerance, sensitivity or allergy to any ingredients in the study test meals.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure measured at screening.
- Change in body weight of >3.5kg within 4 weeks of the screening visit.
- Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Pregnancy or breastfeeding (pregnancy diagnosed on medical history at each visit)
- Any history of an eating disorder (e.g. anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a qualified health professional.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oatmeal + OatWell28XF Intervention 1
2g β-glucan
|
Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.
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EXPERIMENTAL: Oatmeal + OatWell28XF Intervention 2
4g β-glucan
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Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.
|
EXPERIMENTAL: Oatmeal + OatWell28XF Intervention 3
4g β-glucan plus β-glucanase
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Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.
|
PLACEBO_COMPARATOR: Cream of Rice
27 grams of cream of rice
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Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount in caloric content of ingested food at a subsequent meal
Time Frame: 3 hours post consumption
|
Amount in caloric content of ingested food at a subsequent meal in response to Oatmeal containing 4 g oat β-glucan compared to Cream of Rice cereal, in normal-weight and overweight subjects.
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3 hours post consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount in caloric content of ingested food at a subsequent meal
Time Frame: 0-3 hours post consumption
|
Amount in caloric content of ingested food at a subsequent meal in response to Oatmeal containing 2 g oat β-glucan compared to Cream of Rice cereal, in normal-weight and overweight subjects.
|
0-3 hours post consumption
|
rate of gastric emptying
Time Frame: 0-3 hours post consumption
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after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan
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0-3 hours post consumption
|
postprandial responses of blood glucose
Time Frame: 0-3 hours post consumption
|
after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan
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0-3 hours post consumption
|
postprandial responses of serum insulin
Time Frame: 0-3 hours post consumption
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after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan
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0-3 hours post consumption
|
postprandial responses of gut hormone ghrelin
Time Frame: 0-3 hours post consumption
|
after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan
|
0-3 hours post consumption
|
postprandial responses of gut hormone PYY
Time Frame: 0-3 hours post consumption
|
after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan
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0-3 hours post consumption
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subjective ratings of appetite
Time Frame: 0-4.5 hours post consumption
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after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan
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0-4.5 hours post consumption
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Wolever, MD, Glycemic Index Laboratories, Inc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 7, 2017
Primary Completion (ACTUAL)
November 28, 2017
Study Completion (ACTUAL)
November 28, 2017
Study Registration Dates
First Submitted
March 26, 2018
First Submitted That Met QC Criteria
March 31, 2018
First Posted (ACTUAL)
April 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2019
Last Update Submitted That Met QC Criteria
November 27, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP-1613
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data
IPD Sharing Time Frame
Late 2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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