Skip to content

An exploratory clinical study to evaluate changes in lipid profile in healthy human subjects following consumption of potato chips fried in cottonseed oil versus Refined Palmolein oil.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075051
Enrollment
34
Registered
2024-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Test Food A: Potato Chips fried in Cotton Seed oil: Mode of Usage: Subjects will consume 100 g of potato chips at morning breakfast, following at least 12 hours fasting period, with the

Sponsors

Tirupati agrotech private limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age: Adults: 18 to 65 years (both inclusive) at the time of consent 2)Sex: Adults (males and non-pregnant or non-lactating females). 3)Females of childbearing potential should have a self-reported negative urine pregnancy test. 4)Subjects are generally in good general health as determined from a recent medical history, except for the atopic dermatitis.5)Subjects having stable weight for greater or equal to 3 month before the study. 6)Subjects are not allowed to participate in any other study until this study is complete. 7)Subjects must be willing and able to follow the study directions and to return for all specified visits with the subject.8)Subjects willing to follow the study instruction and restrictions. 9)Subject must read, sign, and receive a copy of Informed Consent prior to initiate of study procedures.

Exclusion criteria

Exclusion criteria: 1)Subjects who use of lipid-lowering medication.2)Subjects having history of CVD. 3)Subjects having type 1 or type 2 diabetes.4)Subjects having hypertension. 5)Subjects having sensitivity towards taste and smell of oil. 6)Subjects having history of gastrointestinal disorders. 7)Subjects that are pregnant and/or breastfeeding. 8)Change in current prescriptions (within 4 weeks of screening) or new and/or additional prescriptions for dyslipidaemia (within 4 weeks of screening) or during the study. 9)The subject must not have participated in a clinical study within 4 weeks prior to the screening visit of this study. 10)Any other condition which could warrant exclusion from the study, as per the study physician. 11)History of chronic illness which may influence the study results.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety of the test foods in terms of 1. change in lipid profile before and after consumption of the food 2.change in CBC, biochemistry, random blood sugar, uric acid, urinalysis before and after consumption of the test food Timepoint: Within 7 days from Day 01, after 12 hours of fasting on Day 01 and further 04 hours of fasting at Day 01, and on Day 02 and Day 05 2.Within 07 days from Day 01, and on Day 05

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in9909013286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026