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NCT Number: NCT02841618

The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,

The purpose of this study is to understand how consuming healthy cookies every day for two weeks will affect different types of fat in the blood. Specifically, the overall goal of this study is to find out if the healthy cookies can increase a polyunsaturated fat called linoleic acid in plasma, red blood cells and white blood cells.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Human Nutrition Laboratory

Columbus, Ohio, United States

About this study

Overall, linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin. It is therefore imperative to develop foods products that allow for Americans to easily increase their intake of linoleic acid. It's also important to understand the mechanism in which linoleic acid exerts these positive health effects, particularly in states of muscle mass and quality loss associated with mitochondria dysfunction.

The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims

Aim 1: To determine the extent to which cookies, made with grapeseed oil , increase linoleic acid in plasma, red blood cells (RBCs), and peripheral blood mononuclear cells (PBMCs) fraction of blood after two weeks consumption

Aim 2: To determine the extent to which cookies, made with grapeseed oil, increase cardiolipin and linoleic acid content of cardiolipin in PBMCs after two weeks of consumption

Aim 3: To determine and compare the acceptability of consuming cookies made with grapeseed oil or high oleic safflower oil every day for two weeks

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Nonsmokers

Exclusion criteria

  • Current or previous diagnosis of diabetes, heart (including stroke or heart attack), kidney, liver or circulatory diseases and/or current treatment for cancer.
  • Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
  • Food Allergy or Intolerance & Bee allergy
  • Any dietary restriction where consumption of these healthy cookies or any ingredient would be contraindicated
  • Use of medications where consuming the healthy cookies would be contraindicated
  • Use of supplements/oils high in linoleic acid in the past 4 weeks prior to enrolling
  • Pregnancy

Treatment and study plan

High Linoleic Acid Healthy Cookies

Other

High Oleic Acid Healthy Cookies

Other

Primary outcomes

  1. Changes in fasting fatty acid levels

    Time frame: Baseline through Week 02

    Linoleic acid content of fasting blood samples

  2. Changes in cardiolipin

    Time frame: Baseline through Week 02

    Cardiolipin content in fasting blood samples

  3. Acceptability of Cookies

    Time frame: Baseline through Week 02

    9-point sensory evaluation of healthy cookies

Secondary outcomes

  1. Correlation of linoleic acid in the blood with body strength

    Time frame: Baseline through Week 02

    grip strength measurement

  2. Correlation of linoleic acid in the blood with body movement

    Time frame: Baseline through Week 02

    gait speed measurement

  3. Correlation of linoleic acid in blood with body size

    Time frame: Baseline through Week 02

    Body Mass Index measurement

  4. Correlation of linoleic acid in blood with body shape

    Time frame: Baseline through Week 02

    Abdominal thickness measurement

  5. Correlation of linoleic acid in blood with sleep

    Time frame: Baseline through Week 02

    Sleeping questionnaire

  6. Correlation of linoleic acid in blood with physical activity

    Time frame: Baseline through Week 02

    Physical Activity questionnaire

  7. Correlation of fatty acids in blood with diet

    Time frame: Baseline through Week 02

    omega-3 fat intake questionnaire

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2016
Registry last updated
Apr 21, 2026

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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