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

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ClinicalTrials.gov Identifier: NCT03091946
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief 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.

Condition or disease Intervention/treatment Phase
Blood Glucose; Subjective Hunger, Insulin Other: Overnight oats with additional dried fruits, nuts and seeds Other: Cooked cream of rice with additional dried fruits, nuts and seeds Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Glycemic and Insulinemic Impact of Oats With Additional Dried Fruits, Nuts and Seeds Soaked Overnight in Skim Milk Versus Cream of Rice With Additional Dried Fruits, Nuts and Seeds
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
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
Cooked cream of rice

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
Oatmeal




Primary Outcome Measures :
  1. incremental area under the blood glucose curve [ Time Frame: 0-120 min ]
    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.


Secondary Outcome Measures :
  1. subjective hunger using Visual Analog Scale (VAS) [ Time Frame: below baseline at 120, 180 and 240 min ]
    subjective hunger will be measured using VAS below baseline at 120, 180 and 240 min,

  2. incremental areas under the curve (iAUC) of blood glucose [ Time Frame: 0-180 min ]
    incremental areas under the curve (iAUC) of blood glucose from 0-180 min

  3. iAUC of serum insulin [ Time Frame: 0-120 min and 0-180 min ]
    iAUC of serum insulin from 0-120 min and 0-180 min



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091946


Locations
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Canada
University of Manitoba
Winnipeg, Canada
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Peter Jones, PhD University of Manitoba

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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT03091946     History of Changes
Other Study ID Numbers: PEP-1703
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PepsiCo Global R&D:
Oatmeal; Post-prandial glycemic response ; Post-prandial insulin response; Post-prandial hunger