Dietary Oils to Sustain Energy Study

Overweight and Obesity Clinical Trial

— DOSE  

Official title:

Dietary Oils to Sustain Energy (DOSE) Study: Understanding How Consumption of Dietary Oils in Foods Influences Blood Fatty Acids and Body Weight

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04975763
• Other study ID #: 2021H0232
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research study is an intervention and feasibility crossover design pilot study designed to assess if consuming 3 study foods made with either soybean oil or palm oil per day for 4 weeks can alter whole blood, plasma and erythrocyte fatty acids and body weight in overweight/obese adults. Additionally, the study will assess the adherence to consuming 3 study foods per day for 4 weeks and to assess if participant remain unaware of (or masked to) which study food group (soybean oil vs palm oil) they are consuming.

Description:

The objectives of the study include

• To determine changes in whole blood, plasma and erythrocyte linoleic acid after 4 weeks of consuming 3 foods products made soybean oil and determine changes in plasma and erythrocyte oleic acid and palmitic acid after 4 weeks of consuming 3 food products per day made with palm oil in overweight/obese adults

• To determine changes in body weight in overweight/obese adults during four weeks of consuming 3 food products per day made with soybean oil and during four weeks of consuming 3 food products per day made with palm oil

• To determine if there is evidence of unmasking of the two food product groups (soybean oil or palm oil) during the study in participants and in study coordinators

• To determine adherence of consuming 3 food products per day made with either soybean or palm oil for 4 weeks in overweight/obese adults

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 25-80 years old

• Nonsmokers

• BMI 25-55 kg/m2

Exclusion Criteria:

• Current or previous diagnosis of heart, kidney, and some liver diseases

• Current or previous diagnosis some circulatory diseases and some autoimmune diseases

• Treatment of current cancer diagnosis or current cancer diagnosis

• Current or previous diagnosis of diabetes

• Gastrointestinal diseases or disorders (including pancreatic) that influence nutrient digestion and absorption or gastric bypass surgery

• Alcohol or drug abuse

• Inability to access veins for venipuncture

• Hypothyroidism or Hyperthyroidism diagnosis

• Food Allergy or intolerances

• Any dietary restriction where consumption of the study foods or any ingredient would be contraindicated

• Use of medications where consuming the study foods would be contraindicated

• Use of supplements or medications for weight loss or following a weight loss program

• Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling

• Pregnancy and lactation

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Soybean Oil Foods
Three food product containing 10g of soybean oil each will be consumed each day for a today of 30g of soybean oil consumed each day
• Palm Oil Foods
Three food product containing 10g of palm oil each will be consumed each day for a today of 30g of palm oil consumed each day

Locations

Country	Name	City	State
United States	The Ohio State University Human Nutrition Laboratory	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 blood fatty acid composition	Determine changes in whole blood, plasma and erythrocyte linoleic acid in the soybean oil arm and determine the changes in whole blood, plasma and erythrocyte oleic acid and palmitic acid in the palm oil arm. Fatty acids for all sample types are reported as percent of total identified	Week 0, Week 2, Week 4, Week 6, Week 8, Week 10
Secondary	Changes in body weight	Determine changes in body weight in the soybean oil and palm oil arms	Week 0, Week 2, Week 4, Week 6, Week 8, Week 10
Secondary	Evidence of unmasking	Determine if there is evidence of unmasking of the two food product groups (soybean oil or palm oil) during the study in participants and in study coordinators using a questionnaire and calculating the Bang Blinding Index scale ranging from -1 to 1 with -1 is opposite guessing, 1 is lack of blinding and 0 is blinding	Week 4 and Week 10
Secondary	Adherence to study food consumption	Determine adherence of consuming 3 food products per day made with either soybean or palm oil through self report and returning of uneaten foods	Week 2, Week 4, Week 8, Week 10