CClinicalTrials.gg
CompletedNCT03091946Updated Feb 1, 2018

Glycemic and Insulinemic Impact of Oats With Additional Dried Fruits, Nuts and Seeds Soaked Overnight

An interventional study of Overnight oats with additional dried fruits, nuts and seeds and Cooked cream of rice with additional dried fruits, nuts and seeds in Blood Glucose; Subjective Hunger, Insulin, sponsored by PepsiCo Global R&D. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by PepsiCo Global R&D · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to compare the glucose, insulin and subjective hunger responses elicited by oats with additional dried fruits, nuts and seeds soaked overnight in skim milk and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds cooked just prior to its consumption.

02

Conditions studied

  • Blood Glucose; Subjective Hunger, Insulin

Keywords

  • Oatmeal; Post-prandial glycemic response ; Post-prandial insulin response; Post-prandial hunger
03

In context

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 101 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Male or non-pregnant females, 18-75 years of age, inclusive

  • Body mass index (BMI) between 20.00 and 34.99 kg/m² inclusive at screening (visit 1).
  • Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
  • 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 Richardson Centre. Failure to comply will result in a rescheduled test visit.
  • Normal fasting serum glucose (\<6.3mmol/L).
  • Willing to abstain from alcohol consumption for 24 h prior to all test visits.
  • Willing to avoid vigorous physical activity for 24 h prior to all test visits.
  • 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

Exclusion Criteria:

  • Failure to meet any one of the inclusion criteria
  • 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, 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. Jones, the director of the Richardson Centre, 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.
  • Known to be pregnant or lactating
  • Unwillingness or inability to comply with the experimental procedures and to follow Richardson Centre safety guidelines.
  • Known intolerance, sensitivity or allergy to any ingredients in the study products.
  • 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).
  • Exposure to any investigational drug product within 30 d prior to screening.
  • Participation in any clinical trial 30 days prior to the start of this study.
  • Participation in a PepsiCo clinical study in the past year.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    Cooked cream of rice

    Cream of rice with additional dried fruits, nuts and seeds cooked just prior to its consumption and served with skim milk as a beverage

    Other: Cooked cream of rice with additional dried fruits, nuts and seeds

  • Experimental
    Overnight oats

    Oats with additional dried fruits, nuts and seeds soaked overnight in skim milk

    Other: Overnight oats with additional dried fruits, nuts and seeds

Interventions

  • OtherOvernight oats with additional dried fruits, nuts and seeds

    Oatmeal

  • OtherCooked cream of rice with additional dried fruits, nuts and seeds

    Cooked cream of rice

06

What researchers measure

Primary outcomes

  1. incremental area under the blood glucose curve

    The primary objective of this study is to compare the incremental area under the blood glucose curve from 0-120 min elicited by available carbohydrate matched portions of oats with additional dried fruits, nuts and seeds soaked overnight in skim milk and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds.

    Time frame: 0-120 min

Secondary outcomes

  1. subjective hunger using Visual Analog Scale (VAS)

    subjective hunger will be measured using VAS below baseline at 120, 180 and 240 min,

    Time frame: below baseline at 120, 180 and 240 min

  2. incremental areas under the curve (iAUC) of blood glucose

    incremental areas under the curve (iAUC) of blood glucose from 0-180 min

    Time frame: 0-180 min

  3. iAUC of serum insulin

    iAUC of serum insulin from 0-120 min and 0-180 min

    Time frame: 0-120 min and 0-180 min

07

Study locations

1 site
  • University of Manitoba
    Winnipeg, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03091946
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Mar 27, 2017
Start date
Aug 1, 2017
Primary completion
Nov 1, 2017
Completion
Dec 31, 2017
Last update
Feb 1, 2018

Study contacts

Peter Jones, PhD
principal investigator · University of Manitoba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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