Effect of Prickly Pear fruit consumption on postprandial blood lipids and Physiological Responses

Not Applicable

Completed

• Conditions: Broadly-hypercholesterolemia; Broadly-Hyperlipidemia; Broadly- risk factors of Metabolic syndrome; Broadly- risk factors of Cardiovascular disease; Diet and Nutrition - Other diet and nutrition disorders; Cardiovascular - Hypertension; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Other metabolic disorders; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12618001560280
• Lead Sponsor: Faculty of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-18
• Study Completion: 2019-11-22
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Participants will be included if they are: male; aged between 18-65; a BMI of 18.5-25; no history of cardiovascular disease or known risk factors of CVD (i.e. high cholesterol, high blood pressure, diabetes, obesity, physical inactivity and history of smoking), hepatic, gastrointestinal or renal diseases; not allergic or intolerant to dairy, egg, wheat (gluten), maize (corn); and do not adhere to vegetarian (no egg and/or dairy) or vegan diets.

Exclusion Criteria

Recruited participants are to be excluded under the following circumstances, to ensure the participants safety.
Exclusion Criteria
Participants will be excluded from the study if they are; not with in a BMI of 18.5-25; have a history of cardiovascular disease; have self-reported/known risk factors of CVD (i.e. high cholesterol, high blood pressure, diabetes, obesity, physical inactivity and history of smoking), hepatic, gastrointestinal or renal diseases; use medications or supplements including antibiotics; lipid-lowering therapies such as; statins, fibrates (including clofibrate and ciprofibrate) and lipid-lowering therapies (ezetimibe, colesevelam, torcetrapib, avasimibe, implitapide, niacin aspirin and clopidogrel therapy, Angiotensin-Converting Enzyme (ACE/ABC) therapy) within the 6 weeks prior to clinic 1. Additionally, participants will be excluded in cases where participants are suffering with substance abuse or use tobacco products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial lipid status (Composite-Total Cholesterol; Total Triglyceride, High-Density Lipoprotein-Cholesterol (HDL-C), Low-Density Lipoprotein-Cholesterol (LDL-C), Very Low-Density Lipoprotein-Cholesterol (VLDL-C); ELISA Kits and Friedwald Equation)<br><br><br>[Single consumption; Blood collection and physiological responses at 0,1, 2 and 3 hours];Physiological responses (Composite-Blood Pressure (SBP, DBP), Heart Rate Variability (HRV), Pulse Wave Velocity (PWV), Respiratory Exchange Ratio (RER))[Single consumption; Blood collection and physiological responses at 0,1, 2 and 3 hours]

Secondary Outcome Measures

Name	Time	Method
Associated digestion indicators (Composite-Glucose, Insulin, Nitric Oxide (NO) and Antioxidant characteristics/changes (DPPH, CUPRAC, FRAP, ABTS; ELISA Kits; as per protocol)[Single consumption; Blood collection and physiological responses at 0,1, 2 and 3 hours]