- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02599272
Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study (PSP)
Study Overview
Status
Conditions
Detailed Description
Spices have been used for centuries to enhance food flavouring and to maintain health. Use of spices as a culinary ingredient is common amongst people of all ethnicities within South and East Asia. Spices are also one of the main sources of polyphenols in the Asian diet. Several in vitro studies and some in vivo studies, mainly in animals have shown that individual spices, including turmeric (containing curcumin), cinnamon (cinnimic acid), ginger, garlic etc. have been shown to improve glucose and lipid metabolism.However, well-controlled randomised trials, within the normal dietary context in humans are limited.
This study will be conducted using a three-way randomised crossover design using the Latin square approach. In the two treatment sessions, each volunteer will consume a mixed spice dish at two doses (i.e., 'small portion' or 'large portion' curry sauce), and rice as the base ingredient. In the control session, the same base ingredient (rice) but without the mixed spices will be served. The total amount of mixed spices consumed, to be made from dried powders of turmeric, cumin, coriander, gooseberry (amla), cinnamon, clove and cayenne pepper, will be 6 g and 12 g for small and large portion curries respectively. In addition, as added vegetables, the curry meals will contain tomato, garlic, onion and ginger, whereas the control meal will just have tomato and peeled aubergine, although, the total amount of vegetables will remain the same across all dishes (treatment or control).
The primary objective of this study will be to measure postprandial and fasting changes in blood glucose, insulin, triglycerides (TG), free fatty acids (FFA), 24h ambulatory blood pressure (BP), endothelial function and inflammatory markers following consumption of increasing doses of mixed spices in a single meal, on separate occasions.
The secondary objective of the study will be to monitor changes in blood levels of gut hormones, plasma and urine metabolome including polyphenols such as benzoate and hippurate, gut microflora content and function, as a result of the mixed spice intake. A subset of the treatments (control and high spice dose only) will also have interstitial glucose monitored continuously for a period of up to 3 days using the continuous glucose monitoring system (CGMS).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Rice with vegetables but no added spice
Control session - rice with control vegetables (tomatoes and aubergines) - no mixed spices
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Dose 0
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Active Comparator: Rice with vegetables and low spice
Dose 1 mixed spice session - rice with 6 g powdered mixed spices and 40 g polyphenol rich vegetables (onions, ginger and garlic)
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Dose 1, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, peeled aubergine, onion, ginger and garlic
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Active Comparator: Rice with vegetables and high spice
Dose 2 mixed spice session - rice with 12 g powdered mixed spices and 80 g polyphenol rich vegetables (onions, ginger and garlic)
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Dose 2, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, onion, ginger and garlic
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial changes in interstitial glucose concentration
Time Frame: Up to 48 hours from baseline, taken every 5 minutes
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Postprandial changes in interstitial glucose concentration using continuous glucose monitoring (CGM) following consumption of increasing doses of mixed spices in a single meal
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Up to 48 hours from baseline, taken every 5 minutes
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Postprandial changes in plasma insulin concentration
Time Frame: Up to 48 hours from baseline
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Postprandial changes in plasma insulin concentration following consumption of increasing doses of mixed spices in a single meal
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Up to 48 hours from baseline
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Postprandial changes in plasma triglyceride concentration
Time Frame: Up to 48 hours from baseline
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Postprandial changes in plasma triglyceride concentration following consumption of increasing doses of mixed spices in a single meal
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Up to 48 hours from baseline
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Postprandial changes in plasma free fatty acid (FFA) concentration
Time Frame: Up to 48 hours from baseline
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Postprandial changes in plasma free fatty acid (FFA) concentration following consumption of increasing doses of mixed spices in a single meal
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Up to 48 hours from baseline
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Postprandial changes in plasma interleukin-6 (IL-6) concentration
Time Frame: Up to 48 hours from baseline
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Postprandial changes in plasma IL-6 concentration following consumption of increasing doses of mixed spices in a single meal
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Up to 48 hours from baseline
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Postprandial changes in plasma inter-cellular adhesion molecule (ICAM-1) concentration
Time Frame: Up to 48 hours from baseline
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Postprandial changes in plasma inter-cellular adhesion molecule (ICAM-1) concentration following consumption of increasing doses of mixed spices in a single meal
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Up to 48 hours from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monitor changes in blood levels of glucagon like peptide 1 (GLP-1)
Time Frame: Up to 48 hours from baseline
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Monitor changes in blood levels of glucagon like peptide 1 (GLP-1) as a result of the mixed spice intake
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Up to 48 hours from baseline
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Monitor changes in blood levels of glucose dependent insulinotropic peptide (GIP)
Time Frame: Up to 48 hours from baseline
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Monitor changes in blood levels of GIP as a result of the mixed spice intake
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Up to 48 hours from baseline
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Monitor changes in blood levels of peptide YY (PYY)
Time Frame: Up to 48 hours from baseline
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Monitor changes in blood levels of PYY as a result of the mixed spice intake
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Up to 48 hours from baseline
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Monitor changes in plasma metabolome (metabolomics)
Time Frame: Up to 48 hours from baseline
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Monitor changes in plasma metabolome including benzoate and hippurate as a result of the mixed spice intake
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Up to 48 hours from baseline
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Monitor changes in urine metabolome (metabolomics)
Time Frame: Up to 48 hours from baseline
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Monitor changes in urine metabolome including hippurate and benzoate as a result of the mixed spice intake
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Up to 48 hours from baseline
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Monitor changes in gut microbiome
Time Frame: Up to 2 days before and up to 8 days after baseline
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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)
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Up to 2 days before and up to 8 days after baseline
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015/00729
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