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Active, Not Recruiting

NCT Number: NCT04975763

Dietary Oils to Sustain Energy Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Human Nutrition Laboratory

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soybean Oil Foods

Other

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

Other

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

Primary outcomes

  1. Changes in blood fatty acid composition

    Time frame: Week 0, Week 2, Week 4, Week 6, Week 8, Week 10

    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

Secondary outcomes

  1. Changes in body weight

    Time frame: Week 0, Week 2, Week 4, Week 6, Week 8, Week 10

    Determine changes in body weight in the soybean oil and palm oil arms

  2. Evidence of unmasking

    Time frame: Week 4 and Week 10

    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

  3. Adherence to study food consumption

    Time frame: Week 2, Week 4, Week 8, Week 10

    Determine adherence of consuming 3 food products per day made with either soybean or palm oil through self report and returning of uneaten foods

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Acronym: DOSE

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 23, 2021
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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