NCT03911427|Completed
Oat and Cholesterol
Impact of Oat Product on LDL Cholesterol in Healthy Men and Women With Elevated LDL-cholesterol
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Impact of Oat Product on LDL Cholesterol in Healthy Men and Women With Elevated LDL-cholesterol
Sponsor study identifier
interventional
207
1 country
1
Study Start
April 10, 2019
Actual (reported)Primary Completion
February 20, 2020
Actual (reported)Study Completion
February 28, 2020
Actual (reported)The primary objective is to assess the effect of an oat ingredient provided over 4 weeks on serum LDL cholesterol in men and women with elevated LDL-cholesterol compared to a placebo. Secondary endpoints are fasting serum total- and HDL-cholesterol, non-HDL-cholesterol, triglycerides, glucose, insulin, glycated albumin, HOMA-IR and Framingham risk score
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 9, 2019
Actual (reported)April 10, 2019
Actual (reported)April 11, 2019
Actual (reported)February 20, 2020
Actual (reported)February 28, 2020
Actual (reported)Change in fasting serum LDL-cholesterol
Reduction in mmol/L is a better outcome and \>=5% reduction would be significant
Baseline vs. Week 4
Change in fasting serum total cholesterol
Baseline vs. Week 4
Change in fasting serum HDL cholesterol
Baseline vs. Week 4
Change in fasting non-HDL-cholesterol
Baseline vs. Week 4
Change in fasting triglycerides
Baseline vs. Week 4
Change in fasting glucose
Baseline vs. Week 4
Oat powder product, mixed with water
Brown rice milk powder product, mixed with water
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor
Toronto, Ontario, M5C 2N8, Canada
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.
Thomas MS Wolever, MD, PhD
Glycemic Index Laboratories, Inc
207 participants (actual enrollment reported by the registry).
First Submitted
April 9, 2019
First Posted
April 11, 2019
Study Start
April 10, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 20, 2020
Actual (reported)Study Completion
February 28, 2020
Actual (reported)Last Updated
March 23, 2020
Record last verified: 2020-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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