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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose; Subjective Hunger, Insulin
• Intervention / Treatment: Other: Cooked cream of rice with additional dried fruits, nuts and seeds; Other: Overnight oats with additional dried fruits, nuts and seeds

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Winnipeg, Canada
    • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-120 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective hunger using Visual Analog Scale (VAS)	subjective hunger will be measured using VAS below baseline at 120, 180 and 240 min,	below baseline at 120, 180 and 240 min
incremental areas under the curve (iAUC) of blood glucose	incremental areas under the curve (iAUC) of blood glucose from 0-180 min	0-180 min
iAUC of serum insulin	iAUC of serum insulin from 0-120 min and 0-180 min	0-120 min and 0-180 min

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Peter Jones, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Oatmeal; Post-prandial glycemic response ; Post-prandial insulin response; Post-prandial hunger
• Other Study ID Numbers: PEP-1703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No