Hypercholesterolemia

500 mg Phyllanthus emblica L. fresh fruit extract capsules

AMX160

500 mg roasted rice powder in visually identical capsules

Placebo

Clinic of General and Invasive Cardiology University Hospital 1, YSMU

Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia

The change over time from the baseline to end of treatment, both within and between the group.

Data sharing can be carried out through a proper research proposal to the scientific review board of Arjuna Natural Ltd except in cases where Arjuna Natural Ltd. has no legal authority because the product has been out-licensed to another company or there is no feasible means to anonymise the data and redact personally identifiable information without compromising the privacy and confidentiality of research participants.

Arjuna Natural Limited

Control session - rice with control vegetables (tomatoes and aubergines) - no mixed spices

Dose 1 mixed spice session - rice with 6 g powdered mixed spices and 40 g polyphenol rich vegetables (onions, ginger and garlic)

Dose 2 mixed spice session - rice with 12 g powdered mixed spices and 80 g polyphenol rich vegetables (onions, ginger and garlic)

Cardiometabolic Risk

Rice with tomatoes and peeled aubergine (no spice)

Dose 1, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, peeled aubergine, onion, ginger and garlic

Rice with vegetables and low spice

Dose 2, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, onion, ginger and garlic

Rice with vegetables and high spice

Clinical Nutrition Research Centre

Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study

Postprandial changes in interstitial glucose concentration using continuous glucose monitoring (CGM) following consumption of increasing doses of mixed spices in a single meal

Postprandial changes in plasma insulin concentration following consumption of increasing doses of mixed spices in a single meal

Postprandial changes in plasma triglyceride concentration following consumption of increasing doses of mixed spices in a single meal

Postprandial changes in plasma free fatty acid (FFA) concentration following consumption of increasing doses of mixed spices in a single meal

Postprandial changes in plasma IL-6 concentration following consumption of increasing doses of mixed spices in a single meal

Postprandial changes in plasma inter-cellular adhesion molecule (ICAM-1) concentration following consumption of increasing doses of mixed spices in a single meal

Monitor changes in blood levels of glucagon like peptide 1 (GLP-1) as a result of the mixed spice intake

Monitor changes in blood levels of GIP as a result of the mixed spice intake

Monitor changes in blood levels of PYY as a result of the mixed spice intake

Monitor changes in plasma metabolome including benzoate and hippurate as a result of the mixed spice intake

Monitor changes in urine metabolome including hippurate and benzoate as a result of the mixed spice intake

Stool samples will be collected at baseline (3 days and 1 day before) and up to 7 days following consumption of curry (1, 3 and 7 days after collection)

ribes cereum/triglyceride

Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia

Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study

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