- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841618
The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States
- The Ohio State University Human Nutrition Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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