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

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ClinicalTrials.gov Identifier: NCT01350284
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
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  ICMJE May 3, 2011
First Posted Date  ICMJE May 9, 2011
Last Update Posted Date May 9, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses.
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Gastric Emptying
  • Diabetes Mellitus
Intervention  ICMJE
  • 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  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2011)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01350284
Other Study ID Numbers  ICMJE CinnGastEmpt
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amir Shafat, PhD, University of Limerick
Study Sponsor  ICMJE University of Limerick
Collaborators  ICMJE
  • University of Ulster
  • Ulster Hospital, Northern Ireland
  • National University of Ireland, Galway, Ireland
Investigators  ICMJE
Principal Investigator: Amir Shafat, PhD Univeristy of Limerick
PRS Account University of Limerick
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP