Clinical Nutrition Research Centre
Singapore, 117599
NCT Number: NCT02599272
The study will investigate whether having mixed spices rich in polyphenols can improve postprandial cardiometabolic response in healthy Chinese men.
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Notify Me21 year–40 year
Male
Interventional
Not applicable
Singapore, 117599
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose 0
Dose 1, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, peeled aubergine, onion, ginger and garlic
Dose 2, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, onion, ginger and garlic
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
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
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
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
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
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
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
Time frame: Up to 48 hours from baseline
Monitor changes in blood levels of GIP as a result of the mixed spice intake
Time frame: Up to 48 hours from baseline
Monitor changes in blood levels of PYY as a result of the mixed spice intake
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
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
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)
Singapore Institute of Food and Biotechnology Innovation
Other Gov
Acronym: PSP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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