The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast

Conditions
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Gastric Emptying, Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Cinnamon
* Dietary Supplement: Placebo control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplementation<br>3g of cinnamon or placebo control were added to a test-meal. | Dietary Supplement: Cinnamon<br>* acute oral administration of 3 g cinnamon<br>Dietary Supplement: Placebo control<br>* 3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of 3grams cinnamon on gastric emptying half time |  | During the 6.5 hours post ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness | Post-prandial changes in pulse wave velocity (m/s) will be measured non-invasively, using Pulsetrace PSA2 to indicate arterial stiffness. | 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. | 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. | 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). | During the 6.5 hours after ingestion | 
| Oxidative stress | Serum lipidhydroperoxides will be measured using FOX-1 assay. | 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. | 6 hours post-prandially | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidants, Glucose Intolerance prevention and control, Diabetes Mellitus prevention and control