Clinical trial NCT02035241: Effect of Herbs and Spices on Metabolic Regulation and Appetite in Healthy Subjects
Official title: Investigation on Effect of Herbs and Spices on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Spices
Herbs
Functional food
Cardiometabolic risk
Metabolic syndrome
Inflammation
Appetite
Gut hormone
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Anti-Diabetic Food Centre
First posted: 2014-01-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate how herbs and spices affect acute/postprandial glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue scales) in healthy volunteers. We hypothesize that certain herbs and spices added to a standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers, compared with a similar meal without the corresponding plant materials.

Detailed description: The aims of the study is to investigate whether consumption of preload isovolumetric (220 ml) spice-based beverages contained total polyphenol concentration to 185 mg gallic-acid equivalents followed by white wheat bread challenge (contained 50 g available carbohydrate) might affect postprandial glucose metabolism, inflammatory markers, appetite-related gut hormones, plasma antioxidant capacity, as well as appetite sensations in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females
* Signed informed consent
* BMI 20 - 28 kg/m2 with weight change \<3 kg latest 2 months)
* Must be able to accept herbs and spices

Exclusion Criteria:

* Below 18 years
* Uncomfortable speaking English and/or difficulties in understanding spoken English
* Smoking or using snuff
* Vegetarian or vegan
* Stressed by venous blood sampling or previous experience of being difficult to cannulate
* Receiving any drug treatment that may influence the study outcomes
* Pregnancy or breastfeeding

Primary outcomes:
measure: Changing on blood glucose concentration after treatment with herbs and spices
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Secondary outcomes:
measure: Changing on subjective appetite ratings after treatment with herbs and spices
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
measure: Changing on metabolic biomarkers after treatment with herbs and spices
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
measure: Changing on urine metabolite profile after treatment with herbs and spices
timeFrame: Prior to the initial intervention at 0 min and up to 24-h after intervention
measure: Changing on plasma metabolite profile after treatment with herbs and spices
timeFrame: Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Antidiabetic Food Centre (Medicon Village) - Lund University
state: Skane
Study officials:
affiliation: Lund University
name: Elin Östman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Yoghatama Cindya Zanzer, MSc
role: PRINCIPAL_INVESTIGATOR
References: