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
• Sponsor: University of Limerick
• Collaborators: University of Ulster; Ulster Hospital, Northern Ireland; National University of Ireland, Galway, Ireland
• Information provided by: University of Limerick

Tracking Information

• First Submitted Date: May 3, 2011
• First Posted Date: May 9, 2011
• Last Update Posted Date: May 9, 2011
• Study Start Date: June 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 6, 2011): The effect of 3grams cinnamon on gastric emptying half time [ Time Frame: During the 6.5 hours post ingestion ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 6, 2011)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Basic Science

Condition

• Gastric Emptying
• Diabetes Mellitus

Intervention

• 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

Study Arms

Experimental: Dietary supplementation

3g of cinnamon or placebo control were added to a test-meal.

Interventions:

• Dietary Supplement: Cinnamon
• Dietary Supplement: Placebo control

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2011): 9
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ireland

Administrative Information

• NCT Number: NCT01350284
• Other Study ID Numbers: CinnGastEmpt
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Amir Shafat, PhD, University of Limerick
• Study Sponsor: University of Limerick

Collaborators

• University of Ulster
• Ulster Hospital, Northern Ireland
• National University of Ireland, Galway, Ireland

Investigators

• Principal Investigator: Amir Shafat, PhD; Univeristy of Limerick

• PRS Account: University of Limerick
• Verification Date: May 2011