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

Diabetes Mellitus Clinical Trial

— CinnGastEmpt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350284
• Other study ID #: CinnGastEmpt
• Status: Completed
• Phase: N/A
• First received: May 3, 2011
• Last updated: May 6, 2011
• Start date: June 2009
• Est. completion date: March 2010

Study information

• Verified date: May 2011
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gastric Emptying

Intervention

Dietary Supplement:
• Cinnamon
acute oral administration of 3 g cinnamon
• Placebo control
3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention

Locations

Country	Name	City	State
Ireland	Department of Physical Education & Sport Sciences, University of Limerick	Limerick

Sponsors (4)

Lead Sponsor	Collaborator
University of Limerick	National University of Ireland, Galway, Ireland, Ulster Hospital, Northern Ireland, University of Ulster

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of 3grams cinnamon on gastric emptying half time		During the 6.5 hours post ingestion	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Oxidative stress	Serum lipidhydroperoxides will be measured using FOX-1 assay.	During the 6.5 hours after ingestion	No
Secondary	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	No