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

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ClinicalTrials.gov Identifier: NCT02599272
Recruitment Status : Completed
First Posted : November 6, 2015
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
National University Hospital, Singapore
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

Brief Summary:
The study will investigate whether having mixed spices rich in polyphenols can improve postprandial cardiometabolic response in healthy Chinese men.

Condition or disease Intervention/treatment Phase
Cardiometabolic Risk Other: Rice with tomatoes and peeled aubergine (no spice) Other: Rice with vegetables and low spice Other: Rice with vegetables and high spice Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study
Actual Study Start Date : October 7, 2015
Actual Primary Completion Date : March 26, 2018
Actual Study Completion Date : March 26, 2018

Arm Intervention/treatment
Rice with vegetables but no added spice
Control session - rice with control vegetables (tomatoes and aubergines) - no mixed spices
Other: Rice with tomatoes and peeled aubergine (no spice)
Dose 0

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

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




Primary Outcome Measures :
  1. Postprandial changes in interstitial glucose concentration [ Time Frame: Up to 48 hours from baseline, taken every 5 minutes ]
    Postprandial changes in interstitial glucose concentration using continuous glucose monitoring (CGM) following consumption of increasing doses of mixed spices in a single meal

  2. Postprandial changes in plasma insulin concentration [ Time Frame: Up to 48 hours from baseline ]
    Postprandial changes in plasma insulin concentration following consumption of increasing doses of mixed spices in a single meal

  3. Postprandial changes in plasma triglyceride concentration [ Time Frame: Up to 48 hours from baseline ]
    Postprandial changes in plasma triglyceride concentration following consumption of increasing doses of mixed spices in a single meal

  4. Postprandial changes in plasma free fatty acid (FFA) concentration [ Time Frame: Up to 48 hours from baseline ]
    Postprandial changes in plasma free fatty acid (FFA) concentration following consumption of increasing doses of mixed spices in a single meal

  5. Postprandial changes in plasma interleukin-6 (IL-6) concentration [ Time Frame: Up to 48 hours from baseline ]
    Postprandial changes in plasma IL-6 concentration following consumption of increasing doses of mixed spices in a single meal

  6. Postprandial changes in plasma inter-cellular adhesion molecule (ICAM-1) concentration [ Time Frame: Up to 48 hours from baseline ]
    Postprandial changes in plasma inter-cellular adhesion molecule (ICAM-1) concentration following consumption of increasing doses of mixed spices in a single meal


Secondary Outcome Measures :
  1. Monitor changes in blood levels of glucagon like peptide 1 (GLP-1) [ Time Frame: Up to 48 hours from baseline ]
    Monitor changes in blood levels of glucagon like peptide 1 (GLP-1) as a result of the mixed spice intake

  2. Monitor changes in blood levels of glucose dependent insulinotropic peptide (GIP) [ Time Frame: Up to 48 hours from baseline ]
    Monitor changes in blood levels of GIP as a result of the mixed spice intake

  3. Monitor changes in blood levels of peptide YY (PYY) [ Time Frame: Up to 48 hours from baseline ]
    Monitor changes in blood levels of PYY as a result of the mixed spice intake

  4. Monitor changes in plasma metabolome (metabolomics) [ Time Frame: Up to 48 hours from baseline ]
    Monitor changes in plasma metabolome including benzoate and hippurate as a result of the mixed spice intake

  5. Monitor changes in urine metabolome (metabolomics) [ Time Frame: Up to 48 hours from baseline ]
    Monitor changes in urine metabolome including hippurate and benzoate as a result of the mixed spice intake

  6. Monitor changes in gut microbiome [ Time Frame: Up to 2 days before and up to 8 days after baseline ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599272


Locations
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Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
Sponsors and Collaborators
Clinical Nutrition Research Centre, Singapore
National University Hospital, Singapore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT02599272     History of Changes
Other Study ID Numbers: 2015/00729
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018