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Study protocol
Evaluation of the Acute Effects of Traditional Persian Medicine Based Hot and Cold Foods on Metabolic Responses and Arterial Stiffness in Healthy Men: Study Protocol for a Randomized Controlled Trial
Malihe Motavasselian
Mashhad University of Medical Sciences
Corresponding Author
ORCiD: https://orcid.org/0000-0003-4543-8252
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Traditional Persian Medicine (TPM)-based temperament is affected by some determinant factors that seems to have close similarities to resting energy expenditure (REE) and thermic effect of food (TEF) determinants. Pulse characteristics is considered as a main tool distinguishing different temperaments and vascular function and the probability of cardiovascular events are different in hot and cold-temper individuals in TPM point of view. Additionally, all foods are divided into cold/hot-temper and dry/wet-temper in this medical school and may lead to different responses in subjects regarding their temperaments.
Methods: This experiment will be an acute phase study that will be performed on two groups of healthy individuals with normal body mass index (BMI) with hot and cold temperament. Each person will receive two TPM-based hot/cold isocaloric breakfast meals in 2 different days and metabolic responses and arterial stiffness indices thorough blood samples, indirect calorimetry, and pulse wave analysis and velocimetry will be assessed at fasting state, 0.5, 2, and 4 hours following meal consumption.
Discussion: We will investigate the metabolic differences between individuals with TPM-based hot and cold temperaments and also to evaluate the effects of different TPM-based temperament of isocaloric meals (hot and cold) on metabolic responses and arterial stiffness indices in TPM-based hot/cold temper healthy men in this study. The results of this research project may lead to design of novel combined TPM and modern nutrition-based diet planning to improve metabolic responses and vascular reactivity.
Trial registration: International Clinical Trials Registry Platform IRCT20200417047105N1, retrospectively registered at 19/04/2020. URL: https://irct.ir/trial/47267.
Keywords
Arterial Stiffness, Metabolic Responses, Temperament
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Evaluation of the Acute Effects of Traditional Persian Medicine Based Hot and Cold Foods on Metabolic Responses and Arterial Stiffness in Healthy Men: Study Protocol for a Randomized Controlled Trial
Malihe Motavasselian
Mashhad University of Medical Sciences
Corresponding Author
ORCiD: https://orcid.org/0000-0003-4543-8252
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 22 Dec, 2020
No community comments so far
Editor assigned
On 21 Dec, 2020
Submission checks complete
On 17 Dec, 2020
First submitted
On 26 Sep, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Traditional Persian Medicine (TPM)-based temperament is affected by some determinant factors that seems to have close similarities to resting energy expenditure (REE) and thermic effect of food (TEF) determinants. Pulse characteristics is considered as a main tool distinguishing different temperaments and vascular function and the probability of cardiovascular events are different in hot and cold-temper individuals in TPM point of view. Additionally, all foods are divided into cold/hot-temper and dry/wet-temper in this medical school and may lead to different responses in subjects regarding their temperaments.
Methods: This experiment will be an acute phase study that will be performed on two groups of healthy individuals with normal body mass index (BMI) with hot and cold temperament. Each person will receive two TPM-based hot/cold isocaloric breakfast meals in 2 different days and metabolic responses and arterial stiffness indices thorough blood samples, indirect calorimetry, and pulse wave analysis and velocimetry will be assessed at fasting state, 0.5, 2, and 4 hours following meal consumption.
Discussion: We will investigate the metabolic differences between individuals with TPM-based hot and cold temperaments and also to evaluate the effects of different TPM-based temperament of isocaloric meals (hot and cold) on metabolic responses and arterial stiffness indices in TPM-based hot/cold temper healthy men in this study. The results of this research project may lead to design of novel combined TPM and modern nutrition-based diet planning to improve metabolic responses and vascular reactivity.
Trial registration: International Clinical Trials Registry Platform IRCT20200417047105N1, retrospectively registered at 19/04/2020. URL: https://irct.ir/trial/47267.