The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,

NCT02841618 | Active Not Recruiting

• 1 other identifier: 2015H0209
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand how consuming healthy cookies every day for two weeks will affect different types of fat in the blood. Specifically, the overall goal of this study is to find out if the healthy cookies can increase a polyunsaturated fat called linoleic acid in plasma, red blood cells and white blood cells.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (3)

• Changes in fasting fatty acid levels

  Linoleic acid content of fasting blood samples

  Baseline through Week 02

• Changes in cardiolipin

  Cardiolipin content in fasting blood samples

  Baseline through Week 02

• Acceptability of Cookies

  9-point sensory evaluation of healthy cookies

  Baseline through Week 02

Secondary Outcomes (7)

• Correlation of linoleic acid in the blood with body strength

  Baseline through Week 02

• Correlation of linoleic acid in the blood with body movement

  Baseline through Week 02

• Correlation of linoleic acid in blood with body size

  Baseline through Week 02

• Correlation of linoleic acid in blood with body shape

  Baseline through Week 02

• Correlation of linoleic acid in blood with sleep

  Baseline through Week 02

Study Arms (2)

High Linoleic Acid Healthy Cookies

EXPERIMENTAL

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

Other: High Linoleic Acid Healthy Cookies

High Oleic Acid Healthy Cookies

PLACEBO COMPARATOR

High Oleic Acid Healthy Cookies (10g safflower oil) 1 per day for 2 weeks Matched for Phase 2: N=42 adults

Other: High Oleic Acid Healthy Cookies

Interventions

High Oleic Acid Healthy Cookies OTHER

High Oleic Acid Healthy Cookies

High Linoleic Acid Healthy Cookies OTHER

High Linoleic Acid Healthy Cookies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonsmokers

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Human Nutrition Laboratory

Columbus, Ohio, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two Phases: Phase 1: Single arm, grapeseed oil cookie (N=39 adults) Phase 2: Triple masked, grapeseed or safflower oil cookie (N=84 adults)

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 22, 2016
• Study Start: January 1, 2016
• 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)