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Elevated LDL CholesterolNCT03911427

Oat and Cholesterol

A study testing Active oat beverage in people with Elevated LDL Cholesterol, run by PepsiCo Global R&D at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Elevated LDL Cholesterol
What is being tested?
Active oat beverage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
207 participants
Where
1 siteCanada
Study dates
10 Apr 2019to 28 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Fasting LDL cholesterol 116-193 mg/dl (3-5 mmol/L)
  • Males and non-pregnant, non-lactating females 18-65 years
  • Agree to consume the investigational product three times daily for the duration of the study
  • BMI 18.5 to 39.9 kg/m2
  • Blood pressure <160/100 mmHg
  • Fasting triglycerides <4.0 mmol/L
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  • Fasting serum glucose <126mg/dL (<7 mmol/L)
  • Serum urea and creatinine < 1.8 times upper limit of normal (ULN)
  • Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) < 2 times ULN
  • Hemoglobin > 0.9 times lower limit of normal and < 1.1 times ULN
  • Have a stable body weight (<7 kg change) over the past 3-months
  • Absence of health conditions that would prevent fulfillment of study requirements

Who cannot join

  • Pregnancy, breastfeeding or planning to be pregnant
  • Allergy or sensitivity to study product ingredients
  • Dislike description of study product
  • Diet containing ≥15% of energy from saturated fat
  • Consuming >20g fiber/per 1000 Kcal or >40g fiber/day (including soluble fiber supplements)
  • Consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week
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  • Extreme dietary habits
  • Smoking >5 cigarettes or equivalent per day
  • Use of cholesterol lowering medication or prescription drug or for treating diabetes mellitus within 4 weeks of randomization
  • Active major gastrointestinal disorder
  • Major trauma or hospitalization for a medical condition or major surgical event within 6 months of randomization
  • History of cancer within two years or randomization, except for non-melanoma skin cancer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor

    Toronto, Ontario, M5C 2N8

Other trials in Canada

About this study

Official title: Impact of Oat Product on LDL Cholesterol in Healthy Men and Women With Elevated LDL-cholesterol

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

Being tested
Active oat beverage, Control rice beverage
Keywords
Beverage, Beta glucan, Fiber, Oat, Hypercholesterolemia, LDL, Cholesterol
Medical subject headings
Hyperlipoproteinemia Type II, Gyrate Atrophy, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active oat beverageOther

    Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month

  • Control rice beverageOther

    Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month

Study groups in NCT03911427
Study groupRoleWhat they receive
Powder Mix 1ExperimentalOat powder product, mixed with water
Receives: Other: Active oat beverage
Powder Mix 2Placebo comparatorBrown rice milk powder product, mixed with water
Receives: Other: Control rice beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fasting serum LDL-cholesterol

    Reduction in mmol/L is a better outcome and >=5% reduction would be significant

    Measured: Baseline vs. Week 4

Secondary outcomes (9)

  1. Change in fasting serum total cholesterol

    Reduction in mmol/L is a better outcome

    Measured: Baseline vs. Week 4

  2. Change in fasting serum HDL cholesterol

    Increase in mmol/L is a better outcome

    Measured: Baseline vs. Week 4

  3. Change in fasting non-HDL-cholesterol

    Reduction in mmol/L is a better outcome

    Measured: Baseline vs. Week 4

  4. Change in fasting triglycerides

    Reduction in mmol/L is a better outcome

    Measured: Baseline vs. Week 4

  5. Change in fasting glucose

    Reduction in mmol/L is a better outcome

    Measured: Baseline vs. Week 4

  6. Change in fasting insulin

    Reduction in mmol/L is a better outcome

    Measured: Baseline vs. Week 4

  7. Change in fasting glycated albumin

    % reduction is a better outcome. Normal range is 11-17% of total albumin.

    Measured: Baseline vs. Week 4

  8. Change in fasting HOMA-IR

    Reduction is a better outcome. Calculated from serum glucose mmol/L and insulin uU/ml. G×I/22.5, where G is fasting serum glucose in mmol/L and I is fasting serum insulin in uU/mL. Less than 1.0 means insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.

    Measured: Baseline vs. Week 4

  9. Change in Framingham risk score

    Reduction is a better outcome. 10 year risk for cardiovascular disease = total points expressed as % for men and women. Calculated from sex, age, total and HDL cholesterol (mg/dL), systolic blood pressure (mmHg), smoking (yes/no) and diabetes (yes/no) using the equations given on the Framingham Heart Study website.

    Measured: Baseline vs. Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start10 Apr 2019
  3. Primary completion20 Feb 2020
  4. Study completion28 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03911427
Sponsor's protocol ID
PEP-1801
Status last verified
Mar 2020
First submitted
9 Apr 2019
Last updated
23 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34236436

Questions about this trial

What is this clinical trial studying?

A study testing Active oat beverage in people with Elevated LDL Cholesterol, run by PepsiCo Global R&D at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fasting serum LDL-cholesterol (time frame: Baseline vs. Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03911427, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.

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