Cardiometabolic Risk Clinical Trial
— PSPOfficial title:
Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study
Verified date | October 2018 |
Source | Clinical Nutrition Research Centre, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will investigate whether having mixed spices rich in polyphenols can improve postprandial cardiometabolic response in healthy Chinese men.
Status | Completed |
Enrollment | 33 |
Est. completion date | March 26, 2018 |
Est. primary completion date | March 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Chinese Male - Age between 21 to 40 years - Body Mass Index between 18.5 to 27.5 kg/m2 - Waist circumference = 90cm - Fasting blood glucose < 6.0mmol/L - Blood pressure <140mmHg systolic or < 90mmHg diastolic - Do not partake in sports at the competitive and/or endurance levels and willing to stop any strenuous activity during or within 72 hours of test days Exclusion Criteria: - Smoking - Allergic/intolerant to any of the test foods mentioned above, or any of the following common food and ingredients: eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc. - Have difficulty passing motion - Have or had diarrhea in the past 1 month of study participation - Have any metabolic or cardiovascular diseases (e.g., diabetes, heart condition) or any other diseases involving the small intestine or the colon (e.g., irritable bowel syndrome, inflammatory bowel disease, gastric reflux) Have any liver or kidney disorders or any family history of kidney stones - Taking any prescribed medication or dietary supplements which may interfere with the study measurements, including consumption of probiotic drinks or supplements, taking antibiotics, laxatives or antidiarrheal medicines likely to interfere with study findings - Excessive alcohol consumption: consuming alcohol on > 4 days per week with = 6 alcoholic drinks per week - Individuals who have donated blood within the previous 6 months |
Country | Name | City | State |
---|---|---|---|
Singapore | Clinical Nutrition Research Centre | Singapore |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Centre, Singapore | National University Hospital, Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postprandial changes in interstitial glucose concentration | Postprandial changes in interstitial glucose concentration using continuous glucose monitoring (CGM) following consumption of increasing doses of mixed spices in a single meal | Up to 48 hours from baseline, taken every 5 minutes | |
Primary | Postprandial changes in plasma insulin concentration | Postprandial changes in plasma insulin concentration following consumption of increasing doses of mixed spices in a single meal | Up to 48 hours from baseline | |
Primary | Postprandial changes in plasma triglyceride concentration | Postprandial changes in plasma triglyceride concentration following consumption of increasing doses of mixed spices in a single meal | Up to 48 hours from baseline | |
Primary | Postprandial changes in plasma free fatty acid (FFA) concentration | Postprandial changes in plasma free fatty acid (FFA) concentration following consumption of increasing doses of mixed spices in a single meal | Up to 48 hours from baseline | |
Primary | Postprandial changes in plasma interleukin-6 (IL-6) concentration | Postprandial changes in plasma IL-6 concentration following consumption of increasing doses of mixed spices in a single meal | Up to 48 hours from baseline | |
Primary | Postprandial changes in plasma inter-cellular adhesion molecule (ICAM-1) concentration | Postprandial changes in plasma inter-cellular adhesion molecule (ICAM-1) concentration following consumption of increasing doses of mixed spices in a single meal | Up to 48 hours from baseline | |
Secondary | Monitor changes in blood levels of glucagon like peptide 1 (GLP-1) | Monitor changes in blood levels of glucagon like peptide 1 (GLP-1) as a result of the mixed spice intake | Up to 48 hours from baseline | |
Secondary | Monitor changes in blood levels of glucose dependent insulinotropic peptide (GIP) | Monitor changes in blood levels of GIP as a result of the mixed spice intake | Up to 48 hours from baseline | |
Secondary | Monitor changes in blood levels of peptide YY (PYY) | Monitor changes in blood levels of PYY as a result of the mixed spice intake | Up to 48 hours from baseline | |
Secondary | Monitor changes in plasma metabolome (metabolomics) | Monitor changes in plasma metabolome including benzoate and hippurate as a result of the mixed spice intake | Up to 48 hours from baseline | |
Secondary | Monitor changes in urine metabolome (metabolomics) | Monitor changes in urine metabolome including hippurate and benzoate as a result of the mixed spice intake | Up to 48 hours from baseline | |
Secondary | Monitor changes in gut microbiome | 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) | Up to 2 days before and up to 8 days after baseline |
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