The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses. (CinnGastEmpt)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastric Emptying Diabetes Mellitus |
Dietary Supplement: Cinnamon Dietary Supplement: Placebo control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast |
- The effect of 3grams cinnamon on gastric emptying half time [ Time Frame: During the 6.5 hours post ingestion ] [ Designated as safety issue: No ]
- Arterial stiffness [ Time Frame: During the 6.5 hours after ingestion ] [ Designated as safety issue: No ]Post-prandial changes in pulse wave velocity (m/s) will be measured non-invasively, using Pulsetrace PSA2 to indicate arterial stiffness.
- Lipaemia [ Time Frame: During the 6.5 hours after ingestion ] [ Designated as safety issue: No ]Plasma concentration (mmol/l) of triacylglycerols, LDL, and HDL will be measured every hour in the post-prandial period.
- Glycemia [ Time Frame: During the 6.5 hours after ingestion ] [ Designated as safety issue: No ]The concentration of plasma glucose (mmol/l) will measured hourly in the postprandial period, using venous blood drawn from a forearm vein.
- Appetite [ Time Frame: During the 6.5 hours after ingestion ] [ Designated as safety issue: No ]Subjective sensation of hunger, desire to eat, fullness, thirst, tiredness and coldness will be meaured using a 150mm visual analogue scale (mm).
- Oxidative stress [ Time Frame: During the 6.5 hours after ingestion ] [ Designated as safety issue: No ]Serum lipidhydroperoxides will be measured using FOX-1 assay.
- Food intake [ Time Frame: 6 hours post-prandially ] [ Designated as safety issue: No ]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.
| Enrollment: | 9 |
| Study Start Date: | June 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dietary supplementation
3g of cinnamon or placebo control were added to a test-meal.
|
Dietary Supplement: Cinnamon
acute oral administration of 3 g cinnamon
Dietary Supplement: Placebo control
3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease.
- Allergies to foods in study.
- Blood disorder
- Pregnancy.
Contacts and Locations| Ireland | |
| Department of Physical Education & Sport Sciences, University of Limerick | |
| Limerick, Ireland | |
| Principal Investigator: | Amir Shafat, PhD | Univeristy of Limerick |
More Information
No publications provided by University of Limerick
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amir Shafat, PhD, University of Limerick |
| ClinicalTrials.gov Identifier: | NCT01350284 History of Changes |
| Other Study ID Numbers: | CinnGastEmpt |
| Study First Received: | May 3, 2011 |
| Last Updated: | May 6, 2011 |
| Health Authority: | Ireland: Research Ethics Committee |
Keywords provided by University of Limerick:
|
Antioxidants Glucose Intolerance prevention and control Diabetes Mellitus prevention and control |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013