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Trial record 3 of 93 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

Oat and Cholesterol

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ClinicalTrials.gov Identifier: NCT03911427
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Glycemic Index Laboratories, Inc
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief 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.

Secondary endpoints are fasting serum total- and HDL-cholesterol, non-HDL-cholesterol, triglycerides, glucose, insulin, glycated albumin, HOMA-IR and Framingham risk score


Condition or disease Intervention/treatment Phase
Elevated LDL Cholesterol Other: Active oat beverage Other: Control rice beverage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Oat Product on LDL Cholesterol in Healthy Men and Women With Elevated LDL-cholesterol
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Powder Mix 1
Oat powder product, mixed with water
Other: Active oat beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month

Placebo Comparator: Powder Mix 2
Brown rice milk powder product, mixed with water
Other: Control rice beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month




Primary Outcome Measures :
  1. Change in fasting serum LDL-cholesterol [ Time Frame: Baseline vs. Week 4 ]
    Reduction in mmol/L is a better outcome and >=5% reduction would be significant


Secondary Outcome Measures :
  1. Change in fasting serum total cholesterol [ Time Frame: Baseline vs. Week 4 ]
    Reduction in mmol/L is a better outcome

  2. Change in fasting serum HDL cholesterol [ Time Frame: Baseline vs. Week 4 ]
    Increase in mmol/L is a better outcome

  3. Change in fasting non-HDL-cholesterol [ Time Frame: Baseline vs. Week 4 ]
    Reduction in mmol/L is a better outcome

  4. Change in fasting triglycerides [ Time Frame: Baseline vs. Week 4 ]
    Reduction in mmol/L is a better outcome

  5. Change in fasting glucose [ Time Frame: Baseline vs. Week 4 ]
    Reduction in mmol/L is a better outcome

  6. Change in fasting insulin [ Time Frame: Baseline vs. Week 4 ]
    Reduction in mmol/L is a better outcome

  7. Change in fasting glycated albumin [ Time Frame: Baseline vs. Week 4 ]
    % reduction is a better outcome. Normal range is 11-17% of total albumin.

  8. Change in fasting HOMA-IR [ Time Frame: Baseline vs. Week 4 ]
    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.

  9. Change in Framingham risk score [ Time Frame: Baseline vs. Week 4 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Fasting LDL cholesterol 116-193 mg/dl (3-5 mmol/L)
  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:

  1. Pregnancy, breastfeeding or planning to be pregnant
  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 >14g fiber/1000 Kcal (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

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): NCT03911427


Contacts
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Contact: Janice Campbell 416 861 0506 ext 201 JCampbell@gilabs.com

Locations
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Canada, Ontario
Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor Recruiting
Toronto, Ontario, Canada, M5C 2N8
Contact: Janice Campbell    +1 416-861-0506    JCampbell@gilabs.com   
Principal Investigator: Tomas Wolever, MD, PhD         
Sponsors and Collaborators
PepsiCo Global R&D
Glycemic Index Laboratories, Inc
Investigators
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Principal Investigator: Thomas MS Wolever, MD, PhD Glycemic Index Laboratories, Inc

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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT03911427     History of Changes
Other Study ID Numbers: PEP-1801
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Beverage
Beta glucan
Fiber
Oat
Hypercholesterolemia
LDL
Cholesterol