An Exploratory, Interventional, Prospective, Randomized, Cross-Over, Two-Arm, Clinical Study to evaluate the safety of Test Food(s) (i.e. Potato Chips Fried in Cotton Seed Oil Vs. Potato Chips Fried in Refined Palmolein Oil) on lipid profiles in Healthy Human Subjects.

This exploratory, interventional, prospective, randomized, cross-over, two-period, two-arm clinical trial evaluated the safety and impact of potato chips deep-fried in refined Cottonseed oil versus potato chips deep fried in refined Palmolein oil on lipid profiles in healthy adults aged 18 to 65 years. A total of 34 participants were enrolled and completed the study, which was registered with the Clinical Trial Registry of India (CTRI/2024/10/075051) on October 10, 2024. Subjects were screened by the NovoBliss Research screening department following Ethics Committee approved protocol standards and internal standard operating procedures.

Study Procedure and Methodology

The study was conducted over three distinct periods to assess the effects of Cottonseed oil consumption on lipid metabolism. Each period followed a structured protocol, including fasting conditions, sample collection, and data analysis, ensuring a rigorous and standardized approach**.**

Day 01 (Period I): Baseline Assessment

On the first day of the study, subjects arrived at the clinical site after a mandatory 12-hour overnight fast to ensure accurate baseline lipid profile measurements. Fasting blood samples (0-hour) were collected to establish baseline lipid levels before any dietary intervention. A second blood sample was drawn 4 hours post-fasting to evaluate natural lipid metabolism in the absence of any test food intake. Throughout the period, any adverse events (AEs) and concomitant medications were carefully documented to ensure participant safety and data integrity.

Day 02 (Period II): Test Food Consumption and Lipid Profile Evaluation

Following another 12-hour overnight fast, subjects returned to the clinical site for their second round of assessments. Baseline fasting lipid profile samples were collected before administering the assigned test food, determined based on a randomized allocation. Subjects then consumed the test food as per the study protocol. After ingestion, a post-consumption lipid profile sample was collected 4 hours later to assess acute changes in lipid metabolism. Any adverse events or medical concerns were closely monitored and documented throughout the process.

Day 05 (Period III): Washout Period and Repeat Assessment

After a three-day washout period, designed to minimize any carryover effects from the previous test food intake, subjects underwent a final assessment. Procedures from Period II were repeated, starting with a 12-hour overnight fast, followed by baseline lipid profile collection. Participants again consumed the assigned test food, and post-consumption blood samples were collected 4 hours later to measure lipid profile variations. Additionally, safety laboratory parameters, including hematological and biochemical markers, were assessed to ensure no adverse effects from dietary intervention.

Data Analysis and Statistical Considerations

All collected raw data underwent a thorough quality review before proceeding to statistical analysis. SPSS (Version 29.0.1.0(171)) and Microsoft Excel were used for data processing and interpretation. Statistical significance was set at a 5% level (p < 0.05) to ensure a robust and reliable evaluation of the findings. The structured methodology ensured that the results were both scientifically rigorous and clinically relevant, providing valuable insights into the effects of Cottonseed oil consumption on lipid metabolism.

The findings of this study highlight the potential health benefits and safety of incorporating refined Cottonseed oil into the diet, particularly through its use in deep-frying potato chips. A single consumption of Cottonseed oil demonstrated a favorable impact on lipid profile modulation, evidenced by a significant increase in HDL cholesterol levels and a slight reduction in LDL cholesterol levels—both key factors in maintaining optimal cardiovascular health.

Given these promising results, it can be hypothesized that the exclusive and prolonged use of Cottonseed oil may yield more robust clinical data, further reinforcing its potential as a heart-friendly dietary oil. In-vitro analysis of Cottonseed oil revealed its high linoleic acid content, which has been associated with improved cardiovascular health, reduced inflammation, and better overall fat quality. These attributes make Cottonseed oil a superior choice for frying, particularly when compared to Palmolein oil, which is often linked to higher saturated fat content and less favorable lipid metabolism effects.

Importantly, the study also found that the consumption of Cottonseed oil did not lead to any significant alterations in hematological, biochemical, or renal parameters, confirming its safety for regular dietary use. The observed changes in lipid profiles remained stable and within the normal laboratory range, suggesting no adverse effects on overall health.

Based on these findings, potato chips fried in Cottonseed oil emerge as a safe and potentially beneficial option for consumption, especially for individuals seeking to support cardiovascular health. Future studies with extended durations and larger sample sizes may provide deeper insights into its long-term benefits and clinical significance.