NCT02931643

Brief Summary

This study aims to investigate the effect of mixed of herbs and spices on gene expression of pathways associated with glucose homeostasis, oxidative stress, inflammation and its interrelation with circulating miRNA, in the postprandial phase in healthy human subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 6, 2018

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

October 11, 2016

Last Update Submit

June 4, 2018

Conditions

Healthy

Keywords

SpicesFunctional foodCardiometabolic riskMetabolic syndromeInflammationPeripheral blood mononuclear cellAcutemiRNA

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 4 hr

    The venous blood samples will be taken for isolation of peripheral blood mononuclear cells. Extracted total RNA will then be used for running RNA-microarray (Illumina, San Diego, CA, USA)

    Prior to the initial intervention at 0 hr and after intervention at 4 hr

Secondary Outcomes (15)

  • Postprandial appetite ratings after acute intervention

    Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.

  • Postprandial gastrointestinal tolerance ratings after acute intervention

    Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.

  • Postprandial blood glucose after acute intervention

    Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.

  • Postprandial insulin after acute intervention

    Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.

  • Postprandial triacylglycerol after acute intervention

    Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.

  • +10 more secondary outcomes

Study Arms (2)

High fat challenge breakfast

PLACEBO COMPARATOR

High fat breakfast without mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

Other: High fat challenge breakfast

High fat challenge breakfast with mixed-spices

EXPERIMENTAL

High fat breakfast with mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

Other: High fat challenge breakfast with mixed-spices

Interventions

High fat challenge breakfastOTHER

In this intervention, subjects are asked to consume high fat breakfast without mixed-spices. Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20

High fat challenge breakfast
High fat challenge breakfast with mixed-spicesOTHER

In this intervention, subjects are asked to consume high fat breakfast with mixed-spices. Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20

High fat challenge breakfast with mixed-spices

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females
  • BMI 23-33 kg/m2
  • Must be able to accept spices
  • Agreed and signed informed consent

You may not qualify if:

  • Below 18 years old
  • Uncomfortable speaking English and/or difficulties in understanding spoken English
  • Smoking or using snuss
  • Vegetarian or vegan
  • Having food allergies
  • Stressed by venous blood sampling or previous experience of being difficult to be cannulated
  • Receiving any drug treatment that may influence the study outcomes
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food for Health Science Centre, Lund University

Lund, Skåne County, 22381, Sweden

Location

Related Links

MeSH Terms

Conditions

Metabolic SyndromeInflammation

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yoghatama Cindya Zanzer, MSc PhDcand

    Lund University

    PRINCIPAL INVESTIGATOR

  • Elin Östman, PhD A/Prof

    Lund University

    PRINCIPAL INVESTIGATOR

  • Congyu Xue, BSc

    Lund University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

June 6, 2018

Record last verified: 2016-10

Locations

SE(1)