Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects

Lund University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Other: Fat challenge breakfast; Other: Fat challenge breakfast+spices; Other: Carbohydrate challenge breakfast+spices; Other: Carbohydrate challenge breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT02479334

LUND-AFC-STAGE3-SPICENUTROMICS

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females
• BMI 20-28 kg/m2
• Must be able to accept spices
• Agreed and signed informed consent

Exclusion criteria

• Below 18 years old
• Uncomfortable speaking English and/or difficulties in understanding spoken English
• Smoking or using snuss
• Vegetarian or vegan
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 4 patient groups, including a placebo group

Fat challenge breakfast

Placebo Comparator group

Description:

200 ml control drink (non-energy flavored water) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

Treatment:

Other: Fat challenge breakfast

Fat challenge breakfast+spices

Experimental group

Description:

200 ml spices drink (non-energy flavored water + spices extract) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

Treatment:

Other: Fat challenge breakfast+spices

Carbohydrate challenge breakfast

Placebo Comparator group

Description:

200 ml control drink (non-energy flavored water) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration

Treatment:

Other: Carbohydrate challenge breakfast

Carbohydrate challenge breakfast+spices

Experimental group

Description:

200 ml spices drink (non-energy flavored water + spices extract) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration

Treatment:

Other: Carbohydrate challenge breakfast+spices