Dietary Oils for Obesity

(DOSE Trial)

Overseen By Martha A Belury, Ph.D., RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Weight loss drugs

Disqualifiers: Heart disease, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 16

Duration: 4 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people using medications where consuming the study foods would be a problem. It's best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment Palm Oil Foods and Soybean Oil Foods for obesity?

Research suggests that palm oil may be more effective than soybean oil in limiting fat storage, as palm oil-fed rats showed lower fat pad weight and body fat compared to those fed soybean oil. Additionally, palm oil did not raise cholesterol levels as much as expected, indicating it might be a safer option for managing obesity-related health risks. ^{1 2 3 4 5}

Is palm oil safe for human consumption?

Palm oil is generally considered safe for human consumption and may even have some health benefits, such as reducing blood cholesterol levels and providing antioxidants. However, consuming oxidized palm oil, which can occur during processing, may pose health risks, including potential toxicity to organs like the liver. ^{4 6 7 8 9}

How does the treatment using palm oil and soybean oil foods for obesity differ from other treatments?

This treatment is unique because it explores the effects of different dietary oils, specifically palm oil and soybean oil, on obesity. Unlike other high-fat diets, palm oil may lead to lower fat storage and has beneficial components like tocotrienols and beta-carotene, which can reduce cholesterol and have antioxidant properties. ^{1 3 6 7 8}

Eligibility Criteria

This trial is for overweight or obese adults aged 25-80 who don't smoke and have a BMI between 25-55. It's not suitable for those with heart, kidney, some liver diseases, cancer, diabetes, thyroid disorders, on certain medications including weight loss ones, pregnant or lactating women, substance abusers, people with food allergies/intolerances or specific dietary restrictions.

Inclusion Criteria

Your body mass index (BMI) is between 25 and 55.

Age 25-80 years old

You do not smoke cigarettes.

Exclusion Criteria

Treatment of current cancer diagnosis or current cancer diagnosis

Current or previous diagnosis of diabetes

Inability to access veins for venipuncture

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 3 study foods made with either soybean oil or palm oil per day for 4 weeks

4 weeks

Visits at Week 0, Week 2, and Week 4

Crossover

Participants switch to the alternate oil group and consume 3 study foods per day for another 4 weeks

4 weeks

Visits at Week 6 and Week 8

Follow-up

Participants are monitored for changes in blood fatty acid composition and body weight

2 weeks

Visit at Week 10

Treatment Details

Interventions

• Palm Oil Foods
• Soybean Oil Foods

Trial Overview The study tests if eating foods made with soybean oil versus palm oil affects body fat composition and weight in overweight individuals. Participants will eat three of these foods daily for four weeks without knowing which oil they're consuming to see if there's a difference.

Participant Groups

Group I: Soybean Oil Experimental Treatment 1 Intervention

Consumption of study foods each day made with soybean oil

Group II: Palm Oil Placebo Group 1 Intervention

Consumption of study foods each day made with palm oil

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

Palm oil is nutritionally beneficial and versatile, containing high levels of oleic acid that can help reduce blood cholesterol and improve lipid profiles, making it comparable to olive oil in health benefits.

The unique structure of palm oil allows for better absorption of beneficial fatty acids while minimizing the absorption of saturated fats, contributing to its effectiveness in lowering LDL cholesterol and triglycerides while raising HDL cholesterol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palm oil: a healthful and cost-effective dietary component. Ong, AS., Goh, SH.[2017]

Palm oil, despite being high in saturated fatty acids, does not promote cardiovascular diseases and may actually reduce the risk of arterial thrombosis and atherosclerosis due to its antioxidant content and unique fatty acid composition.

While fresh or refined palm oil can have health benefits, including improved nutrient utilization and immune function, oxidized palm oil poses significant health risks, including adverse effects on lipid profiles and organ toxicity, highlighting the importance of consuming palm oil in its fresh state.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palm oil: biochemical, physiological, nutritional, hematological, and toxicological aspects: a review. Edem, DO.[2022]

Palm oil is not linked to raised blood cholesterol levels and is considered cholesterol-free, with its main saturated fatty acid, palmitic acid, shown to have a neutral effect on cholesterol, especially when LDL receptors are functioning normally.

Feeding studies indicate that palm oil may actually lower blood cholesterol compared to other saturated fat sources like coconut oil and animal fats, and it may also increase HDL levels and reduce platelet aggregation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of palm oil on cardiovascular risk. Chong, YH., Ng, TK.[2017]

References

1. China pubmed.ncbi.nlm.nih.gov

Adipose tissue expansion and the development of obesity: influence of dietary fat type. [2014]

2. Malaysia pubmed.ncbi.nlm.nih.gov

Changing concepts in lipid nutrition in health and disease. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

Fatty acid biosynthesis and lipogenic enzyme activities in subcutaneous adipose tissue of feedlot steers fed supplementary palm oil or soybean oil. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of palm and mixtures of refined palm and soybean oils on serum lipids and fecal fat and fatty acid excretions of adult humans. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Polyunsaturated meat and dairy products in fat-modified food patterns for hyperlipidemia. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Palm oil: a healthful and cost-effective dietary component. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Tropical oils: nutritional and scientific issues. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Palm oil: biochemical, physiological, nutritional, hematological, and toxicological aspects: a review. [2022]

9. Malaysia pubmed.ncbi.nlm.nih.gov

Effects of palm oil on cardiovascular risk. [2017]