Clinical trial NCT01350284: The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses.
Official title: Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Diabetes Mellitus
Keywords: Antioxidants
Glucose Intolerance prevention and control
Diabetes Mellitus prevention and control
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: University of Ulster
name: Ulster Hospital, Northern Ireland
name: National University of Ireland, Galway, Ireland
First posted: 2011-05-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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 criteria: 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.

Primary outcomes:
measure: The effect of 3grams cinnamon on gastric emptying half time
timeFrame: During the 6.5 hours post ingestion
Secondary outcomes:
measure: Arterial stiffness
timeFrame: During the 6.5 hours after ingestion
measure: Lipaemia
timeFrame: During the 6.5 hours after ingestion
measure: Glycemia
timeFrame: During the 6.5 hours after ingestion
measure: Appetite
timeFrame: During the 6.5 hours after ingestion
measure: Oxidative stress
timeFrame: During the 6.5 hours after ingestion
measure: Food intake
timeFrame: 6 hours post-prandially
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: Department of Physical Education & Sport Sciences, University of Limerick
Study officials:
affiliation: Univeristy of Limerick
name: Amir Shafat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.