HealthyAFC-SPICESNCT02035241
Effect of Herbs and Spices on Metabolic Regulation and Appetite in Healthy Subjects
A study testing Spices 1, Spices 2 and Spices 3 in people with Healthy, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Spices 1, Spices 2 and Spices 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2014to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Antidiabetic Food Centre (Medicon Village) - Lund University
Lund, Skåne County, 22381
About this study
Official title: Investigation on Effect of Herbs and Spices on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Spices 1, Spices 2, Spices 3, Herbs 1, Herbs 2
- Keywords
- Spices, Herbs, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Appetite, Gut hormone
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spices 1Dietary supplement
In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Spices 2Dietary supplement
In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Spices 3Dietary supplement
In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 3. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Herbs 1Dietary supplement
In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Herbs 2Dietary supplement
In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Control drinkDietary supplement
As a control, subjects are asked to consume 200 ml control drinks. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
| Study group | Role | What they receive |
|---|---|---|
| Spices 1 | Experimental | 220 ml test drink containing spices 1, acute study / one time administration Receives: Dietary Supplement: Spices 1 |
| Spices 2 | Experimental | 220 ml test drink containing spices 2, acute study / one time administration Receives: Dietary Supplement: Spices 2 |
| Spices 3 | Experimental | 220 ml test drink containing spices 3, acute study / one time administration Receives: Dietary Supplement: Spices 3 |
| Herbs 1 | Experimental | 220 ml test drink containing herbs 1, acute study / one time administration Receives: Dietary Supplement: Herbs 1 |
| Herbs 2 | Experimental | 220 ml test drink containing herbs 2, acute study / one time administration Receives: Dietary Supplement: Herbs 2 |
| Placebo | Placebo comparator | 220 ml control drink, acute study / one time administration Receives: Dietary Supplement: Control drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing on blood glucose concentration after treatment with herbs and spices
The capillary blood samples will be taken for blood glucose analysis
Measured: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Secondary outcomes (4)
Changing on subjective appetite ratings after treatment with herbs and spices
Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit
Measured: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Changing on metabolic biomarkers after treatment with herbs and spices
The venous blood samples will be taken for insulin, inflammatory markers (i.e. interleukin-6, interleukin-8, tumor necrosis factor-alpha, necrosis factor kappa-beta, adiponectin and C-reactive protein), appetite-related gut hormones (i.e. glucagon-like peptide-1 and peptide tyrosine-tyrosine)
Measured: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Changing on urine metabolite profile after treatment with herbs and spices
Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods
Measured: Prior to the initial intervention at 0 min and up to 24-h after intervention
Changing on plasma metabolite profile after treatment with herbs and spices
Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods
Measured: Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Anti-Diabetic Food Centre
- Responsible party
- Principal investigator, Elin Östman, Lund University
- Investigators
- Elin Östman, PhD, Principal investigator, Lund UniversityYoghatama Cindya Zanzer, MSc, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035241
- Sponsor's protocol ID
- LUND-AFC-STAGE3-SPICES
- Acronym
- AFC-SPICES
- Status last verified
- Aug 2018
- First submitted
- 10 Jan 2014
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Effect of Herbs and Spices on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02035241
- Acronym / sponsor ID
- AFC-SPICES / LUND-AFC-STAGE3-SPICES
- Conditions
- Healthy
- Keywords
- Spices, Herbs, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Appetite, Gut hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Anti-Diabetic Food Centre
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Spices 1 | Experimental | Dietary Supplement: Spices 1220 ml test drink containing spices 1, acute study / one time administration |
| Spices 2 | Experimental | Dietary Supplement: Spices 2220 ml test drink containing spices 2, acute study / one time administration |
| Spices 3 | Experimental | Dietary Supplement: Spices 3220 ml test drink containing spices 3, acute study / one time administration |
| Herbs 1 | Experimental | Dietary Supplement: Herbs 1220 ml test drink containing herbs 1, acute study / one time administration |
| Herbs 2 | Experimental | Dietary Supplement: Herbs 2220 ml test drink containing herbs 2, acute study / one time administration |
| Placebo | Placebo comparator | Dietary Supplement: Control drink220 ml control drink, acute study / one time administration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spices 1In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate. | Dietary supplement | Spices 1 |
| Spices 2In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate. | Dietary supplement | Spices 2 |
| Spices 3In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 3. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate. | Dietary supplement | Spices 3 |
| Herbs 1In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate. | Dietary supplement | Herbs 1 |
| Herbs 2In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate. | Dietary supplement | Herbs 2 |
| Control drinkAs a control, subjects are asked to consume 200 ml control drinks. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate. | Dietary supplement | Placebo |
Primary outcome
Changing on blood glucose concentration after treatment with herbs and spices
Time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
The capillary blood samples will be taken for blood glucose analysis
4 secondary outcomes
Changing on subjective appetite ratings after treatment with herbs and spices
Time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Changing on metabolic biomarkers after treatment with herbs and spices
Time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
Changing on urine metabolite profile after treatment with herbs and spices
Time frame: Prior to the initial intervention at 0 min and up to 24-h after intervention
Changing on plasma metabolite profile after treatment with herbs and spices
Time frame: Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Antidiabetic Food Centre - Vinnova Excellence Centre in Research and Innovation at Lund University, SWEDENLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elin Östman, PhD principal investigator
Lund University
Yoghatama Cindya Zanzer, MSc principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spices 1, Spices 2 and Spices 3 in people with Healthy, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing on blood glucose concentration after treatment with herbs and spices (time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.