Cardiometabolic RiskPSPNCT02599272
Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study
A study testing Rice with tomatoes and peeled aubergine (no spice), Rice with vegetables and low spice and Rice with vegetables and high spice in people with Cardiometabolic Risk, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The study will investigate whether having mixed spices rich in polyphenols can improve postprandial cardiometabolic response in healthy Chinese men. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk
- What is being tested?
- Rice with tomatoes and peeled aubergine (no spice), Rice with vegetables and low spice and Rice with vegetables and high spice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Oct 2015to 26 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The study will investigate whether having mixed spices rich in polyphenols can improve postprandial cardiometabolic response in healthy Chinese men.
Read the 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).
- Conditions
- Cardiometabolic Risk
- Being tested
- Rice with tomatoes and peeled aubergine (no spice), Rice with vegetables and low spice, Rice with vegetables and high spice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice with tomatoes and peeled aubergine (no spice)Other
Dose 0
Rice with vegetables and low spiceOther
Dose 1, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, peeled aubergine, onion, ginger and garlic
Rice with vegetables and high spiceOther
Dose 2, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, onion, ginger and garlic
| Study group | Role | What they receive |
|---|---|---|
| Rice with vegetables but no added spice | Other | Control session - rice with control vegetables (tomatoes and aubergines) - no mixed spices Receives: Other: Rice with tomatoes and peeled aubergine (no spice) |
| Rice with vegetables and low spice | Active comparator | Dose 1 mixed spice session - rice with 6 g powdered mixed spices and 40 g polyphenol rich vegetables (onions, ginger and garlic) Receives: Other: Rice with vegetables and low spice |
| Rice with vegetables and high spice | Active comparator | Dose 2 mixed spice session - rice with 12 g powdered mixed spices and 80 g polyphenol rich vegetables (onions, ginger and garlic) Receives: Other: Rice with vegetables and high spice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 48 hours from baseline, taken every 5 minutes
Postprandial changes in plasma insulin concentration
Postprandial changes in plasma insulin concentration following consumption of increasing doses of mixed spices in a single meal
Measured: Up to 48 hours from baseline
Postprandial changes in plasma triglyceride concentration
Postprandial changes in plasma triglyceride concentration following consumption of increasing doses of mixed spices in a single meal
Measured: Up to 48 hours from baseline
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
Measured: Up to 48 hours from baseline
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
Measured: Up to 48 hours from baseline
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
Measured: Up to 48 hours from baseline
Secondary outcomes (6)
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
Measured: Up to 48 hours from baseline
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
Measured: Up to 48 hours from baseline
Monitor changes in blood levels of peptide YY (PYY)
Monitor changes in blood levels of PYY as a result of the mixed spice intake
Measured: Up to 48 hours from baseline
Monitor changes in plasma metabolome (metabolomics)
Monitor changes in plasma metabolome including benzoate and hippurate as a result of the mixed spice intake
Measured: Up to 48 hours from baseline
Monitor changes in urine metabolome (metabolomics)
Monitor changes in urine metabolome including hippurate and benzoate as a result of the mixed spice intake
Measured: Up to 48 hours from baseline
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)
Measured: Up to 2 days before and up to 8 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start7 Oct 2015
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599272
- Sponsor's protocol ID
- 2015/00729
- Other IDs
- 2015
- Acronym
- PSP
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2015
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Haldar S, Pakkiri LS, Lim J, Chia SC, Ponnalagu S, Drum CL, Henry CJ. Reductions in Postprandial Plasma Allantoin Concentrations With Increasing Doses of Polyphenol Rich Curry Intake - A Randomized Crossover Trial. Front Physiol. 2019 Jan 9;9:1899. doi: 10.3389/fphys.2018.01899. eCollection 2018.
PubMed 30687117
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study
- ClinicalTrials.gov ID
- NCT02599272
- Acronym / sponsor ID
- PSP / 2015/00729
- Conditions
- Cardiometabolic Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- National University Hospital, Singapore
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate whether having mixed spices rich in polyphenols can improve postprandial cardiometabolic response in healthy Chinese men.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rice with vegetables but no added spice | Other | Other: Rice with tomatoes and peeled aubergine (no spice)Control session - rice with control vegetables (tomatoes and aubergines) - no mixed spices |
| Rice with vegetables and low spice | Active comparator | Other: Rice with vegetables and low spiceDose 1 mixed spice session - rice with 6 g powdered mixed spices and 40 g polyphenol rich vegetables (onions, ginger and garlic) |
| Rice with vegetables and high spice | Active comparator | Other: Rice with vegetables and high spiceDose 2 mixed spice session - rice with 12 g powdered mixed spices and 80 g polyphenol rich vegetables (onions, ginger and garlic) |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rice with tomatoes and peeled aubergine (no spice)Dose 0 | Other | Rice with vegetables but no added spice |
| Rice with vegetables and low spiceDose 1, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, peeled aubergine, onion, ginger and garlic | Other | Rice with vegetables and low spice |
| Rice with vegetables and high spiceDose 2, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, onion, ginger and garlic | Other | Rice with vegetables and high spice |
Primary outcome
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
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
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
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
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
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
6 secondary outcomes
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 glucose dependent insulinotropic peptide (GIP)
Time frame: Up to 48 hours from baseline
Monitor changes in blood levels of peptide YY (PYY)
Time frame: Up to 48 hours from baseline
Monitor changes in plasma metabolome (metabolomics)
Time frame: Up to 48 hours from baseline
Monitor changes in urine metabolome (metabolomics)
Time frame: Up to 48 hours from baseline
Monitor changes in gut microbiome
Time frame: Up to 2 days before and up to 8 days after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 30687117Haldar S, Pakkiri LS, Lim J, Chia SC, Ponnalagu S, Drum CL, Henry CJ. Reductions in Postprandial Plasma Allantoin Concentrations With Increasing Doses of Polyphenol Rich Curry Intake - A Randomized Crossover Trial. Front Physiol. 2019 Jan 9;9:1899. doi: 10.3389/fphys.2018.01899. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice with tomatoes and peeled aubergine (no spice), Rice with vegetables and low spice and Rice with vegetables and high spice in people with Cardiometabolic Risk, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial changes in interstitial glucose concentration (time frame: Up to 48 hours from baseline, taken every 5 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.