Clinical trial NCT02841618: The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two Phases:

Phase 1: Single arm, grapeseed oil cookie (N=39 adults) Phase 2: Triple masked, grapeseed or safflower oil cookie (N=84 adults)
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in fasting fatty acid levels
timeFrame: Baseline through Week 02
measure: Changes in cardiolipin
timeFrame: Baseline through Week 02
measure: Acceptability of Cookies
timeFrame: Baseline through Week 02
Secondary outcomes:
measure: Correlation of linoleic acid in the blood with body strength
timeFrame: Baseline through Week 02
measure: Correlation of linoleic acid in the blood with body movement
timeFrame: Baseline through Week 02
measure: Correlation of linoleic acid in blood with body size
timeFrame: Baseline through Week 02
measure: Correlation of linoleic acid in blood with body shape
timeFrame: Baseline through Week 02
measure: Correlation of linoleic acid in blood with sleep
timeFrame: Baseline through Week 02
measure: Correlation of linoleic acid in blood with physical activity
timeFrame: Baseline through Week 02
measure: Correlation of fatty acids in blood with diet
timeFrame: Baseline through Week 02
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Human Nutrition Laboratory
state: Ohio
Study officials:
References: