Gastric EmptyingCinnGastEmptNCT01350284
The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses.
A study testing Cinnamon in people with Gastric Emptying and Diabetes Mellitus, run by University of Limerick at 1 site in Ireland.
Trial summary
The purpose of this study is to determine whether 3 g cinnamon was sufficient to delay the gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a healthy adult population. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying, Diabetes Mellitus
- What is being tested?
- Cinnamon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2009to Mar 2010
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-35 years
- Recreationally trained individuals (participate in at least 2hrs/wk of individual/team sport)
- Not currently taking antioxidant or lipid-lowering medication
- Fasting blood lipid, glucose and blood pressure (BP) levels were all within the normal limits.
Who cannot join
- History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease.
- Allergies to foods in study.
- Blood disorder
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Department of Physical Education & Sport Sciences, University of Limerick
Limerick
About this study
Official title: Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast
The purpose of this study is to determine whether 3 g cinnamon was sufficient to delay the gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a healthy adult population.
Read the detailed description
Cinnamon has been shown to delay gastric emptying (GE) of a high-carbohydrate meal and reduce postprandial glycaemia in healthy adults. However, it is dietary fat which is implicated in the etiology and is associated with obesity, type 2 diabetes (T2D) and cardiovascular disease (CVD). We aimed to determine the effect of 3 g cinnamon on GE, postprandial lipemic and glycemic responses, oxidative stress, arterial stiffness, as well as appetite sensations and subsequent food intake following a high-fat (HF) meal.
The effect of acute oral administration of 3 g cinnamon on gastric emptying of a high-fat pancake test meal and subjective appetite sensations by visual analogue scale will be measured for six hours postprandially. During this time course, measurements of postprandial lipemic, glycemic, oxidative stress and arterial stiffness responses will be collected. Subsequently, food intake will be measured using an ad libitum buffet meal. The study will be conducted in a randomized, placebo-controlled, single-blinded manner in 9 healthy subjects.
- Conditions
- Gastric Emptying, Diabetes Mellitus
- Being tested
- Cinnamon, Placebo control
- Keywords
- Antioxidants, Glucose Intolerance prevention and control, Diabetes Mellitus prevention and control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinnamonDietary supplement
acute oral administration of 3 g cinnamon
Placebo controlDietary supplement
3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplementation | Experimental | 3g of cinnamon or placebo control were added to a test-meal. Receives: Dietary Supplement: Cinnamon; Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of 3grams cinnamon on gastric emptying half time
Measured: During the 6.5 hours post ingestion
Secondary outcomes (6)
Arterial stiffness
Post-prandial changes in pulse wave velocity (m/s) will be measured non-invasively, using Pulsetrace PSA2 to indicate arterial stiffness.
Measured: During the 6.5 hours after ingestion
Lipaemia
Plasma concentration (mmol/l) of triacylglycerols, LDL, and HDL will be measured every hour in the post-prandial period.
Measured: During the 6.5 hours after ingestion
Glycemia
The concentration of plasma glucose (mmol/l) will measured hourly in the postprandial period, using venous blood drawn from a forearm vein.
Measured: During the 6.5 hours after ingestion
Appetite
Subjective sensation of hunger, desire to eat, fullness, thirst, tiredness and coldness will be meaured using a 150mm visual analogue scale (mm).
Measured: During the 6.5 hours after ingestion
Oxidative stress
Serum lipidhydroperoxides will be measured using FOX-1 assay.
Measured: During the 6.5 hours after ingestion
Food intake
A buffet meal will be presented to the volunteer 6h after breakfast. Food intake will be monitored covertly by weighing individiual food items before and after presentation. Food intake will be expressed as macronutrient (carbohydrate, fat, protein, water, fibre) and energy intake.
Measured: 6 hours post-prandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster, Ulster Hospital, Northern Ireland, National University of Ireland, Galway, Ireland
- Investigators
- Amir Shafat, PhD, Principal investigator, Univeristy of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350284
- Sponsor's protocol ID
- CinnGastEmpt
- Acronym
- CinnGastEmpt
- Status last verified
- May 2011
- First submitted
- 3 May 2011
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Markey O, McClean CM, Medlow P, Davison GW, Trinick TR, Duly E, Shafat A. Effect of cinnamon on gastric emptying, arterial stiffness, postprandial lipemia, glycemia, and appetite responses to high-fat breakfast. Cardiovasc Diabetol. 2011 Sep 7;10:78. doi: 10.1186/1475-2840-10-78.
PubMed 21899741
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast
- ClinicalTrials.gov ID
- NCT01350284
- Acronym / sponsor ID
- CinnGastEmpt / CinnGastEmpt
- Conditions
- Gastric Emptying, Diabetes Mellitus
- Keywords
- Antioxidants, Glucose Intolerance prevention and control, Diabetes Mellitus prevention and control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- University of Ulster, Ulster Hospital, Northern Ireland, National University of Ireland, Galway, Ireland
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 May 2011 (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 this study is to determine whether 3 g cinnamon was sufficient to delay the gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a healthy adult population.
Detailed description
Cinnamon has been shown to delay gastric emptying (GE) of a high-carbohydrate meal and reduce postprandial glycaemia in healthy adults. However, it is dietary fat which is implicated in the etiology and is associated with obesity, type 2 diabetes (T2D) and cardiovascular disease (CVD). We aimed to determine the effect of 3 g cinnamon on GE, postprandial lipemic and glycemic responses, oxidative stress, arterial stiffness, as well as appetite sensations and subsequent food intake following a high-fat (HF) meal.
The effect of acute oral administration of 3 g cinnamon on gastric emptying of a high-fat pancake test meal and subjective appetite sensations by visual analogue scale will be measured for six hours postprandially. During this time course, measurements of postprandial lipemic, glycemic, oxidative stress and arterial stiffness responses will be collected. Subsequently, food intake will be measured using an ad libitum buffet meal. The study will be conducted in a randomized, placebo-controlled, single-blinded manner in 9 healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplementation | Experimental | Dietary Supplement: Cinnamon, Dietary Supplement: Placebo control3g of cinnamon or placebo control were added to a test-meal. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 18-35 years
- Recreationally trained individuals (participate in at least 2hrs/wk of individual/team sport)
- Not currently taking antioxidant or lipid-lowering medication
- Fasting blood lipid, glucose and blood pressure (BP) levels were all within the normal limits.
Key exclusion criteria (4 listed)
- History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease.
- Allergies to foods in study.
- Blood disorder
- Pregnancy.
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 |
|---|---|---|
| Cinnamonacute oral administration of 3 g cinnamon | Dietary supplement | Dietary supplementation |
| Placebo control3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention | Dietary supplement | Dietary supplementation |
Primary outcome
The effect of 3grams cinnamon on gastric emptying half time
Time frame: During the 6.5 hours post ingestion
6 secondary outcomes
Arterial stiffness
Time frame: During the 6.5 hours after ingestion
Lipaemia
Time frame: During the 6.5 hours after ingestion
Glycemia
Time frame: During the 6.5 hours after ingestion
Appetite
Time frame: During the 6.5 hours after ingestion
Oxidative stress
Time frame: During the 6.5 hours after ingestion
Food intake
Time frame: 6 hours post-prandially
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 9 May 2011.
- Derived from this study: PubMed 21899741Markey O, McClean CM, Medlow P, Davison GW, Trinick TR, Duly E, Shafat A. Effect of cinnamon on gastric emptying, arterial stiffness, postprandial lipemia, glycemia, and appetite responses to high-fat breakfast. Cardiovasc Diabetol. 2011 Sep 7;10:78. doi: 10.1186/1475-2840-10-78.
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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.
Amir Shafat, PhD principal investigator
Univeristy of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinnamon in people with Gastric Emptying and Diabetes Mellitus, run by University of Limerick at 1 site in Ireland.
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 4 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 9 May 2011. 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 Ireland. 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. 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?
The effect of 3grams cinnamon on gastric emptying half time (time frame: During the 6.5 hours post ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350284, which also lists 1 linked publication.
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 9 May 2011.