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OpenTrials
Completed

NCT Number: NCT01925716

Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids

The objectives of this clinical trial are to assess the effects of dietary oils on blood lipids and other aspects of the fasting lipoprotein profile in healthy men and women with elevated cholesterol

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fasting LDL-C level equal to or greater than 130 mg/dL and less than 200 mg/dL at visit 1
  • Fasting triglycerides less than or equal to 350 mg/dL at visit 1

Exclusion criteria

  • Has coronary heart disease or coronary heart disease risk risk equivalent, such as diabetes, atherosclerosis, etc
  • Taking lipid medications intended to alter the lipids profile, including but not limited to statins, bile acid sequestrants, etc.
  • Uncontrolled hypertension (systolic greater than or equal to 160 mm Hg or diastolic greater than or equal to 100 mm Hg)

Treatment and study plan

corn oil

Other

corn oil 56 g/day for 21 days

olive oil

Other

olive oil 56 g /day for 21 days

Primary outcomes

  1. Low Density Lipoprotein cholesterol

    Time frame: Time Frame: baseline (average days -7 and 0) and the end of each treatment period [Treatment 1 averages of days 19 and 21and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks

Secondary outcomes

  1. total cholesterol

    Time frame: baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks

Other outcomes

  1. High density lipoprotein cholesterol

    Time frame: baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks

  2. Non-HDL-Cholesterol

    Time frame: baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks

  3. Triglycerides

    Time frame: baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks

  4. Total cholesterol/HDL-C ratio

    Time frame: baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks

Sponsors and collaborators

Lead sponsor

ACH Food Companies, Inc.

Industry

Collaborators

  • PepsiCo Global R&D

Registry information

Official study title

A Randomized Double Blind Controlled Crossover Trial to Assess the Effects of Dietary Oils on Fasting Lipoprotein Lipids

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 20, 2013
Registry last updated
Aug 21, 2013

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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