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OpenTrials
Completed

NCT Number: NCT03911427

Oat and 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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Active oat beverage

Other

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

Control rice beverage

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Collaborators

  • Glycemic Index Laboratories, Inc

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2019
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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