Who is sponsoring PINC?

PINC is sponsored by University of Leeds.

What condition does PINC study?

PINC studies Hypercholesterolemia, Breast Cancer, Obesity.

What drugs are being tested in PINC?

Interventions: Cholesterol Reducing Strawberry Yogurt Drink (Tesco Ltd), Low Fat Strawberry Yogurt Drinks (Morrisons Ltd).

Last reviewed 2021-05-20 · How we verify

Plant Sterol INtervention for Cancer Prevention (PINC)

NCT04147767 NA UNKNOWN

Several types of human cells convert cholesterol into other molecules, including oxysterols. Oxysterols can promote breast cancer growth and help tumours to spread. Some breast cancer types recruit other cells (host cells) able to produce oxysterols within the local cancer environment. How these other cells help breast tumours metastasize or resist chemotherapy is not well understood, but epidemiological and clinical studies suggest elevated LDL-C is associated with worse survival, poorer response to therapy and an increased propensity for disease relapse in breast cancer patients. In this trial the investigators will test how an LDL-C lowering dietary intervention (using commercially available phytosterol added food products), alters the ability of non-cancer cells (adipocytes, fibroblasts and macrophages) collected from high LDL-C volunteers to change chemotherapy response and metastatic process in breast cancer cells. In this trial, volunteers with high LDL-C levels will be recruited by the University of Leeds, and divided randomly into two arms that cross over. The experimental period (yogurt drink enriched with phytosterols) and placebo period (non-enriched yogurt drink) will each last for 8 weeks, alternated with a 4 weeks of wash-out period. Samples will be collected 4 times (week-0, week-8, week-12, week-20) during the study and will include blood, white blood cells (macrophages), and fat tissue cells. Measurements will include oxysterol, LDL-C and phytosterol concentrations (volunteers' serum/plasma, media from the host cells/breast cancer experimental culture) and how the host cells alter the behaviour of cancer cells in the laboratory.

Details

Lead sponsor	University of Leeds
Phase	NA
Status	UNKNOWN
Enrolment	50
Start date	Mon Feb 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Dec 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Hypercholesterolemia
Breast Cancer
Obesity

Interventions

Cholesterol Reducing Strawberry Yogurt Drink (Tesco Ltd)
Low Fat Strawberry Yogurt Drinks (Morrisons Ltd)

Countries

United Kingdom