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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Emptying Diabetes Mellitus Dietary Supplement: Cinnamon Dietary Supplement: Placebo control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : March 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dietary supplementation
3g of cinnamon or placebo control were added to a test-meal.
 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


Outcome Measures
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Primary Outcome Measures :
  1. The effect of 3grams cinnamon on gastric emptying half time [ Time Frame: During the 6.5 hours post ingestion ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. Oxidative stress [ Time Frame: During the 6.5 hours after ingestion ]
    Serum lipidhydroperoxides will be measured using FOX-1 assay.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350284


Locations
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Ireland
Department of Physical Education & Sport Sciences, University of Limerick
Limerick, Ireland
Sponsors and Collaborators
University of Limerick
University of Ulster
Ulster Hospital, Northern Ireland
National University of Ireland, Galway, Ireland
Investigators
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Principal Investigator: Amir Shafat, PhD Univeristy of Limerick
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amir Shafat, PhD, University of Limerick
ClinicalTrials.gov Identifier: NCT01350284    
Other Study ID Numbers: CinnGastEmpt
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: May 2011
Keywords provided by University of Limerick:
Antioxidants
Glucose Intolerance prevention and control
Diabetes Mellitus prevention and control
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases