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SatietyNCT03490851

The Effect of a Breakfast Meal Containing Oat β-glucan on Food Intake at a Subsequent Meal in Normal-weight and Overweight Subjects

A study testing Oatmeal + OatWell28CF Int 1, Oatmeal + OatWell28CF Int 2 and Oatmeal + OatWell28CF Int 3 in people with Satiety, run by PepsiCo Global R&D at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Satiety
What is being tested?
Oatmeal + OatWell28CF Int 1, Oatmeal + OatWell28CF Int 2 and Oatmeal + OatWell28CF Int 3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteCanada
Study dates
7 May 2017to 28 Nov 2017
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Glycemic Index Laboratories

    Toronto

Other trials in Canada

About this study

Official title: 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.

Conditions
Satiety
Being tested
Oatmeal + OatWell28CF Int 1, Oatmeal + OatWell28CF Int 2, Oatmeal + OatWell28CF Int 3, Cream of Rice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oatmeal + OatWell28CF Int 1Other

    Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.

  • Oatmeal + OatWell28CF Int 2Other

    Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.

  • Oatmeal + OatWell28CF Int 3Other

    Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.

  • Cream of RiceOther

    Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.

Study groups in NCT03490851
Study groupRoleWhat they receive
Oatmeal + OatWell28XF Intervention 1Experimental2g β-glucan
Receives: Other: Oatmeal + OatWell28CF Int 1
Oatmeal + OatWell28XF Intervention 2Experimental4g β-glucan
Receives: Other: Oatmeal + OatWell28CF Int 2
Oatmeal + OatWell28XF Intervention 3Experimental4g β-glucan plus β-glucanase
Receives: Other: Oatmeal + OatWell28CF Int 3
Cream of RicePlacebo comparator27 grams of cream of rice
Receives: Other: Cream of Rice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount in caloric content of ingested food at a subsequent meal

    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.

    Measured: 3 hours post consumption

Secondary outcomes (7)

  1. Amount in caloric content of ingested food at a subsequent meal

    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.

    Measured: 0-3 hours post consumption

  2. rate of gastric emptying

    after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan

    Measured: 0-3 hours post consumption

  3. postprandial responses of blood glucose

    after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan

    Measured: 0-3 hours post consumption

  4. postprandial responses of serum insulin

    after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan

    Measured: 0-3 hours post consumption

  5. postprandial responses of gut hormone ghrelin

    after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan

    Measured: 0-3 hours post consumption

  6. postprandial responses of gut hormone PYY

    after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan

    Measured: 0-3 hours post consumption

  7. subjective ratings of appetite

    after intake of oatmeal containing either 2g, 4g or 4g low MW oat beta-glucan

    Measured: 0-4.5 hours post consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2018
  2. Study start7 May 2017
  3. Primary completion28 Nov 2017
  4. Study completion28 Nov 2017

Resources

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
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03490851
Sponsor's protocol ID
PEP-1613
Status last verified
Nov 2019
First submitted
26 Mar 2018
Last updated
2 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data

Publications

  • Wolever TMS, Tosh SM, Spruill SE, Jenkins AL, Ezatagha A, Duss R, Johnson J, Chu Y, Steinert RE. Increasing oat beta-glucan viscosity in a breakfast meal slows gastric emptying and reduces glycemic and insulinemic responses but has no effect on appetite, food intake, or plasma ghrelin and PYY responses in healthy humans: a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2020 Feb 1;111(2):319-328. doi: 10.1093/ajcn/nqz285.

    PubMed 31828287

Questions about this trial

What is this clinical trial studying?

A study testing Oatmeal + OatWell28CF Int 1, Oatmeal + OatWell28CF Int 2 and Oatmeal + OatWell28CF Int 3 in people with Satiety, run by PepsiCo Global R&D at 1 site in Canada.

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 11 inclusion and 16 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 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Amount in caloric content of ingested food at a subsequent meal (time frame: 3 hours post consumption). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03490851, which also lists 1 linked publication.

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 2 Dec 2019.

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