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Completed

NCT Number: NCT01350284

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

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.

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Key information

Conditions

Gastric Emptying Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Education & Sport Sciences, University of Limerick

Limerick, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cinnamon

Dietary Supplement

acute oral administration of 3 g cinnamon

Placebo Control

Dietary Supplement

3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention

Primary outcomes

  1. The effect of 3grams cinnamon on gastric emptying half time

    Time frame: During the 6.5 hours post ingestion

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CinnGastEmpt

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
May 9, 2011
Registry last updated
May 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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