HCES: The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04677920

Collaborator

(none)

Enrollment

Location

Arm

31.7

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed research is an intervention and feasibility pilot trial designed to determine if short-term consumption of healthy cookies made with an oil rich in linoleic acid can influence mitochondria biology in white blood cells and muscle. The hypothesis of the study is that consuming 1 healthy cookie rich in linoleic acid each day for two weeks will improve mitochondrial biology in white blood cells and muscle.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Other: High Linoleic Acid Healthy Cookies	N/A

Detailed Description

Linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin and mitochondria.

The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following four specific aims

Aim 1) To assess muscle biopsy yield with a micro biopsy needle

Aim 2) To determine the amount of peripheral blood mononuclear cells (PBMC) and muscle needed to measure mitochondria function

Aim 3) To assess the feasibility of measuring mitochondria function on fresh PBMC and muscle samples

Aim 4) To determine the effect of short-term healthy cookies made with linoleic acid rich oil on measures of mitochondrial function in white blood cells and muscle as well as their relationship to lipid composition of the blood, markers of metabolic health and markers of mitochondria biogenesis

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

THE HEALTHY COOKIE ENERGY STUDY: Understanding How Healthy Cookies Affect Mitochondrial Biology

Actual Study Start Date :

Sep 7, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Cookie Group All participants in the study	Other: High Linoleic Acid Healthy Cookies High Linoleic Acid Healthy Cookies (containing about 10g of grapeseed oil) 1 per day for 2 weeks

Arm

Intervention/Treatment

Experimental: Healthy Cookie Group

All participants in the study

Other: High Linoleic Acid Healthy Cookies

High Linoleic Acid Healthy Cookies (containing about 10g of grapeseed oil) 1 per day for 2 weeks

Outcome Measures

Primary Outcome Measures

Changes in mitochondria function [Week 0 to Week 2]
Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle
Changes in cardiolipin species [Week 0 to week 2]
Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle
Correlation of mitochondrial biology in blood and skeletal muscle [Week 0 and week 2]
Correlation of mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle

Secondary Outcome Measures

Changes in fasting fatty acid levels [Week 0 to week 2]
Linoleic acid content of fasting blood samples
Correlation of fatty acids with mitochondrial function and cardiolipin species [Week 0 and week 2]
Correlation of linoleic acid in blood with mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle
Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fats [Week 0 and week 2]
Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of sleep quality using the Pittsburgh Sleep Quality Index, physical activity using the Epic Physical activity short questionnaire and dietary omega-3 intake using the Omega-3 Checklist
Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength [Week 0 and week 2]
Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of body mass index, sagittal diameter, grip strength and gait speed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Nonsmoker

Exclusion Criteria:

Allergy/intolerance to lidocaine
Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
Food Allergy or Intolerance
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
Pregnancy
Use of anticoagulant, antiplatelet, or other blood thinner medications
Diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Martha Belury, Associate Professor, Ohio State University

ClinicalTrials.gov Identifier:

NCT04677920

Other Study ID Numbers:

2020H0352

First Posted:

Dec 21, 2020

Last Update Posted:

Jan 20, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jan 20, 2022