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

NCT02599272 | Completed

• 1 other identifier: 2015/00729
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiometabolic Risk

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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

  Up to 48 hours from baseline

Secondary Outcomes (6)

• Monitor changes in blood levels of glucagon like peptide 1 (GLP-1)

  Up to 48 hours from baseline

• Monitor changes in blood levels of glucose dependent insulinotropic peptide (GIP)

  Up to 48 hours from baseline

• Monitor changes in blood levels of peptide YY (PYY)

  Up to 48 hours from baseline

• Monitor changes in plasma metabolome (metabolomics)

  Up to 48 hours from baseline

• Monitor changes in urine metabolome (metabolomics)

  Up to 48 hours from baseline

Study Arms (3)

Rice with vegetables but no added spice

OTHER

Control session - rice with control vegetables (tomatoes and aubergines) - no mixed spices

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)

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)

Other: Rice with vegetables and high spice

Interventions

Rice with tomatoes and peeled aubergine (no spice) OTHER

Dose 0

Rice with vegetables but no added spice

Rice with vegetables and low spice OTHER

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 low spice

Rice with vegetables and high spice OTHER

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

Rice with vegetables and high spice

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (1)

• 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.

  PMID: 30687117 DERIVED

MeSH Terms

Interventions

Vegetables

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 6, 2015
• Study Start: October 7, 2015
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

SG (1)