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

This study has been completed.
Sponsor:
Collaborators:
University of Ulster
Ulster Hospital, Northern Ireland
National University of Ireland, Galway, Ireland
Information provided by:
University of Limerick
ClinicalTrials.gov Identifier:
NCT01350284
First received: May 3, 2011
Last updated: May 6, 2011
Last verified: May 2011
  Purpose

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 Intervention
Gastric Emptying
Diabetes Mellitus
Dietary Supplement: Cinnamon
Dietary Supplement: Placebo control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Cinnamon on Gastric Emptying, Arterial Stiffness, Postprandial Lipaemia, Glycaemia, and Appetite Responses to High-fat Breakfast

Resource links provided by NLM:


Further study details as provided by University of Limerick:

Primary Outcome Measures:
  • The effect of 3grams cinnamon on gastric emptying half time [ Time Frame: During the 6.5 hours post ingestion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial stiffness [ Time Frame: During the 6.5 hours after ingestion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Serum lipidhydroperoxides will be measured using FOX-1 assay.

  • Food intake [ Time Frame: 6 hours post-prandially ] [ Designated as safety issue: No ]
    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.


Enrollment: 9
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350284

Locations
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
Principal Investigator: Amir Shafat, PhD Univeristy of Limerick
  More Information

No publications provided by University of Limerick

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amir Shafat, PhD, University of Limerick
ClinicalTrials.gov Identifier: NCT01350284     History of Changes
Other Study ID Numbers: CinnGastEmpt
Study First Received: May 3, 2011
Last Updated: May 6, 2011
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University of Limerick:
Antioxidants
Glucose Intolerance prevention and control
Diabetes Mellitus prevention and control

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014