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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02599272
• Date of registration: 23/10/2015
• Prospective Registration: No
• Primary sponsor: Clinical Nutrition Research Centre, Singapore
• Public title: Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study PSP
• Scientific title: Effects of Mixed Spices on Cardiometabolic Function - the PolySPice (PSP) Study
• Date of first enrolment: October 7, 2015
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02599272
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Singapore

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Cardiometabolic Risk

Intervention(s)

Other: Rice with tomatoes and peeled aubergine (no spice)

Other: Rice with vegetables and high spice

Other: Rice with vegetables and low spice

Primary Outcome(s)

Postprandial changes in plasma inter-cellular adhesion molecule (ICAM-1) concentration [Time Frame: Up to 48 hours from baseline]

Postprandial changes in plasma interleukin-6 (IL-6) concentration [Time Frame: Up to 48 hours from baseline]

Postprandial changes in plasma triglyceride concentration [Time Frame: Up to 48 hours from baseline]

Postprandial changes in interstitial glucose concentration [Time Frame: Up to 48 hours from baseline, taken every 5 minutes]

Postprandial changes in plasma free fatty acid (FFA) concentration [Time Frame: Up to 48 hours from baseline]

Postprandial changes in plasma insulin concentration [Time Frame: Up to 48 hours from baseline]

Secondary Outcome(s)

Monitor changes in blood levels of peptide YY (PYY) [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]

Monitor changes in plasma metabolome (metabolomics) [Time Frame: Up to 48 hours from baseline]

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 urine metabolome (metabolomics) [Time Frame: Up to 48 hours from baseline]

Secondary ID(s)

2015/00729

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National University Hospital, Singapore