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

Not Applicable

Active, not recruiting

• Conditions: Healthy Adults
• Interventions: Other: High Linoleic Acid Healthy Cookies

• Registration Number: NCT04677920
• Lead Sponsor: Ohio State University

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.

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 Timeline

• Study Start: 2020-09-07
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-12-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Cookie Group	High Linoleic Acid Healthy Cookies	All participants in the study

Primary Outcome Measures

Name	Time	Method
Changes in cardiolipin species	Week 0 to week 2	Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle
Changes in mitochondria function	Week 0 to Week 2	Mitochondria function measured 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

Name	Time	Method
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

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States