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

The Ohio State University

Status: Active, not recruiting

Conditions: Healthy Adults

Treatments: Other: High Linoleic Acid Healthy Cookies; Other: High Oleic Acid Healthy Cookies

Study type: Interventional

Funder types: Other

Identifiers

NCT02841618

2015H0209

Details and patient eligibility

About

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.

Full 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

Enrollment: 123 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 2 patient groups, including a placebo group

High Linoleic Acid Healthy Cookies

Experimental group

Description:

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

Treatment:

Other: High Linoleic Acid Healthy Cookies

High Oleic Acid Healthy Cookies

Placebo Comparator group

Description:

High Oleic Acid Healthy Cookies (10g safflower oil) 1 per day for 2 weeks Matched for Phase 2: N=42 adults

Treatment:

Other: High Oleic Acid Healthy Cookies