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

NCT04677920 | Active Not Recruiting

• 1 other identifier: 2020H0352
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (3)

• Changes in mitochondria function

  Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle

  Week 0 to Week 2

• Changes in cardiolipin species

  Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle

  Week 0 to week 2

• 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 Outcomes (4)

• Changes in fasting fatty acid levels

  Week 0 to week 2

• Correlation of fatty acids with mitochondrial function and cardiolipin species

  Week 0 and week 2

• 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 with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength

  Week 0 and week 2

Study Arms (1)

Healthy Cookie Group

EXPERIMENTAL

All participants in the study

Other: High Linoleic Acid Healthy Cookies

Interventions

High Linoleic Acid Healthy Cookies OTHER

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

Healthy Cookie Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonsmoker

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: December 21, 2020
• Study Start: September 7, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)