The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses. (CinnGastEmpt)
|ClinicalTrials.gov Identifier: NCT01350284|
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : May 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastric Emptying Diabetes Mellitus||Dietary Supplement: Cinnamon Dietary Supplement: Placebo control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||March 2010|
Experimental: Dietary supplementation
3g of cinnamon or placebo control were added to a test-meal.
Dietary Supplement: Cinnamon
acute oral administration of 3 g cinnamonDietary Supplement: Placebo control
3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention
- The effect of 3grams cinnamon on gastric emptying half time [ Time Frame: During the 6.5 hours post ingestion ]
- Arterial stiffness [ Time Frame: During the 6.5 hours after ingestion ]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 ]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 ]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 ]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 ]Serum lipidhydroperoxides will be measured using FOX-1 assay.
- Food intake [ Time Frame: 6 hours post-prandially ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350284
|Department of Physical Education & Sport Sciences, University of Limerick|
|Principal Investigator:||Amir Shafat, PhD||Univeristy of Limerick|