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Dietary Oils to Sustain Energy Study (DOSE)

The Ohio State University logo

The Ohio State University

Status

Active, not recruiting

Conditions

Overweight and Obesity

Treatments

Other: Soybean Oil Foods
Other: Palm Oil Foods

Study type

Interventional

Funder types

Other

Identifiers

NCT04975763
2021H0232

Details and patient eligibility

About

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.

Full 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

Enrollment

16 estimated patients

Sex

All

Ages

25 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

16 participants in 2 patient groups, including a placebo group

Soybean Oil
Experimental group
Description:
Consumption of study foods each day made with soybean oil
Treatment:
Other: Soybean Oil Foods
Palm Oil
Placebo Comparator group
Description:
Consumption of study foods each day made with palm oil
Treatment:
Other: Palm Oil Foods

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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