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

February 9, 2024 updated by: Martha Belury, Ohio State University
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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States
        • The Ohio State University Human Nutrition Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Linoleic Acid Healthy Cookies
High Linoleic Acid Healthy Cookies (10g grapeseed oil) 1 per day for 2 weeks Phase 1: N=39 adults single arm Phase 2: N=42 adults
Placebo Comparator: High Oleic Acid Healthy Cookies
High Oleic Acid Healthy Cookies (10g safflower oil) 1 per day for 2 weeks Matched for Phase 2: N=42 adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fasting fatty acid levels
Time Frame: Baseline through Week 02
Linoleic acid content of fasting blood samples
Baseline through Week 02
Changes in cardiolipin
Time Frame: Baseline through Week 02
Cardiolipin content in fasting blood samples
Baseline through Week 02
Acceptability of Cookies
Time Frame: Baseline through Week 02
9-point sensory evaluation of healthy cookies
Baseline through Week 02

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of linoleic acid in the blood with body strength
Time Frame: Baseline through Week 02
grip strength measurement
Baseline through Week 02
Correlation of linoleic acid in the blood with body movement
Time Frame: Baseline through Week 02
gait speed measurement
Baseline through Week 02
Correlation of linoleic acid in blood with body size
Time Frame: Baseline through Week 02
Body Mass Index measurement
Baseline through Week 02
Correlation of linoleic acid in blood with body shape
Time Frame: Baseline through Week 02
Abdominal thickness measurement
Baseline through Week 02
Correlation of linoleic acid in blood with sleep
Time Frame: Baseline through Week 02
Sleeping questionnaire
Baseline through Week 02
Correlation of linoleic acid in blood with physical activity
Time Frame: Baseline through Week 02
Physical Activity questionnaire
Baseline through Week 02
Correlation of fatty acids in blood with diet
Time Frame: Baseline through Week 02
omega-3 fat intake questionnaire
Baseline through Week 02

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimated)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2015H0209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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