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

Healthy Adults Clinical Trial

— HCES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04677920
• Other study ID #: 2020H0352
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: December 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 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University	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 mitochondria function	Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle	Week 0 to Week 2
Primary	Changes in cardiolipin species	Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle	Week 0 to week 2
Primary	Correlation of mitochondrial biology in blood and skeletal muscle	Correlation of mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle	Week 0 and week 2
Secondary	Changes in fasting fatty acid levels	Linoleic acid content of fasting blood samples	Week 0 to week 2
Secondary	Correlation of fatty acids with mitochondrial function and cardiolipin species	Correlation of linoleic acid in blood with mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle	Week 0 and week 2
Secondary	Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fats	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	Week 0 and week 2
Secondary	Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength	Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of body mass index, sagittal diameter, grip strength and gait speed	Week 0 and week 2