Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
207 participants
INTERVENTIONAL
2019-04-10
2020-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Secondary endpoints are fasting serum total- and HDL-cholesterol, non-HDL-cholesterol, triglycerides, glucose, insulin, glycated albumin, HOMA-IR and Framingham risk score
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Oats on Lipid Profile
NCT02376660
Health Effects of Oats and Oat Bioactive in Human
NCT03830736
Meta-analysis of Oats for Diabetes Prevention and Management
NCT04631913
The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels
NCT03450395
The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
NCT01666561
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Powder Mix 1
Oat powder product, mixed with water
Active oat beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Powder Mix 2
Brown rice milk powder product, mixed with water
Control rice beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active oat beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Control rice beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Males and non-pregnant, non-lactating females 18-65 years
3. Agree to consume the investigational product three times daily for the duration of the study
4. BMI 18.5 to 39.9 kg/m2
5. Blood pressure \<160/100 mmHg
6. Fasting triglycerides \<4.0 mmol/L
7. Fasting serum glucose \<126mg/dL (\<7 mmol/L)
8. Serum urea and creatinine \< 1.8 times upper limit of normal (ULN)
9. Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) \< 2 times ULN
10. Hemoglobin \> 0.9 times lower limit of normal and \< 1.1 times ULN
11. Have a stable body weight (\<7 kg change) over the past 3-months
12. Absence of health conditions that would prevent fulfillment of study requirements
Exclusion Criteria
2. Allergy or sensitivity to study product ingredients
3. Dislike description of study product
4. Diet containing ≥15% of energy from saturated fat
5. Consuming \>20g fiber/per 1000 Kcal or \>40g fiber/day (including soluble fiber supplements)
6. Consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week
7. Extreme dietary habits
8. Smoking \>5 cigarettes or equivalent per day
9. Use of cholesterol lowering medication or prescription drug or for treating diabetes mellitus within 4 weeks of randomization
10. Active major gastrointestinal disorder
11. Major trauma or hospitalization for a medical condition or major surgical event within 6 months of randomization
12. History of cancer within two years or randomization, except for non-melanoma skin cancer
13. Any condition or substance use which might, in the opinion of the PI, make participation dangerous for the participant, lead to poor attendance or compliance or affect the results
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Glycemic Index Laboratories, Inc
INDUSTRY
PepsiCo Global R&D
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas MS Wolever, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Glycemic Index Laboratories, Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ms Wolever T, Rahn M, Dioum E, Spruill SE, Ezatagha A, Campbell JE, Jenkins AL, Chu Y. An Oat beta-Glucan Beverage Reduces LDL Cholesterol and Cardiovascular Disease Risk in Men and Women with Borderline High Cholesterol: A Double-Blind, Randomized, Controlled Clinical Trial. J Nutr. 2021 Sep 4;151(9):2655-2666. doi: 10.1093/jn/nxab154.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PEP-1801
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.