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

Healthy Adults Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02841618
• Other study ID #: 2015H0209
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: December 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Other:
• High Linoleic Acid Healthy Cookies

• High Oleic Acid Healthy Cookies

Locations

Country	Name	City	State
United States	The Ohio State University Human Nutrition Laboratory	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fasting fatty acid levels	Linoleic acid content of fasting blood samples	Baseline through Week 02
Primary	Changes in cardiolipin	Cardiolipin content in fasting blood samples	Baseline through Week 02
Primary	Acceptability of Cookies	9-point sensory evaluation of healthy cookies	Baseline through Week 02
Secondary	Correlation of linoleic acid in the blood with body strength	grip strength measurement	Baseline through Week 02
Secondary	Correlation of linoleic acid in the blood with body movement	gait speed measurement	Baseline through Week 02
Secondary	Correlation of linoleic acid in blood with body size	Body Mass Index measurement	Baseline through Week 02
Secondary	Correlation of linoleic acid in blood with body shape	Abdominal thickness measurement	Baseline through Week 02
Secondary	Correlation of linoleic acid in blood with sleep	Sleeping questionnaire	Baseline through Week 02
Secondary	Correlation of linoleic acid in blood with physical activity	Physical Activity questionnaire	Baseline through Week 02
Secondary	Correlation of fatty acids in blood with diet	omega-3 fat intake questionnaire	Baseline through Week 02