Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04818905
Other study ID # SMILJ_pilot
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date September 30, 2020

Study information

Verified date March 2021
Source University of Primorska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study evaluates the acute effects of Helichrysum italicum on resting energy expenditure and substrate oxidation in humans. The resting energy expenditure and substrate oxidation will be measured by indirect calorimetry at baseline and after ingestion of either Helichrysum italicum infusion or hot water.


Description:

Bioactive compounds found in medicinal plants and plant extracts, such as polyphenols, represent the oldest and most widely used form of alternative or complementary treatments for the prevention and management of obesity. Their consumption is currently increasing in the population due to the high cost, potential adverse effects and limited benefits of currently available pharmaceutical drugs. Helichrysum italicum is a mediterranean plant with promising nutraceutical activities. The plant is known as a rich source of biologically active compounds such as polyphenolic antioxidants, which are recognized in the prevention of various non-communicable chronic diseases. However, most of its traditionally claimed uses have not yet been scientifically proven. The proposed study will investigate the acute effect of Helichrysum italicum infusion on resting energy expenditure, substrate oxidation, respiratory quotient and blood pressure in a pilot study of 11 male adults. It will be designed as a crossover study. Half of the participants will consume the Helichrysum italicum infusion and the other half will consume hot water. After seven days of washout period the participants will consume the alternate beverage.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date September 30, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - healthy, weight-stable (±3 kg in the last 3 months), normotensive, non-smokers, no use of dietary supplements or frequent use of medication and no known metabolic disorders. Exclusion Criteria: - females, smoking, medications, dietary supplements, metabolic diseases, hypertensive

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Helichrysum italicum infusion
Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.
Other:
Hot water
Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.

Locations

Country Name City State
Slovenia University of Primorska, Faculty of Health Sciences Izola

Sponsors (1)

Lead Sponsor Collaborator
University of Primorska

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

Antunes Viegas D, Palmeira-de-Oliveira A, Salgueiro L, Martinez-de-Oliveira J, Palmeira-de-Oliveira R. Helichrysum italicum: from traditional use to scientific data. J Ethnopharmacol. 2014;151(1):54-65. doi: 10.1016/j.jep.2013.11.005. Epub 2013 Nov 14. Review. — View Citation

Konstantinidi M, Koutelidakis AE. Functional Foods and Bioactive Compounds: A Review of Its Possible Role on Weight Management and Obesity's Metabolic Consequences. Medicines (Basel). 2019 Sep 9;6(3). pii: E94. doi: 10.3390/medicines6030094. Review. — View Citation

Manach C, Scalbert A, Morand C, Rémésy C, Jiménez L. Polyphenols: food sources and bioavailability. Am J Clin Nutr. 2004 May;79(5):727-47. Review. — View Citation

Soga S, Ota N, Shimotoyodome A. Stimulation of postprandial fat utilization in healthy humans by daily consumption of chlorogenic acids. Biosci Biotechnol Biochem. 2013;77(8):1633-6. Epub 2013 Aug 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in resting energy expenditure Resting energy expenditure will be determined with indirect calorimetry. Change from baseline to 30 minutes and 120 minutes.
Primary Changes in fat oxidation Substrate oxidation will be determined with indirect calorimetry. Change from baseline to 30 minutes and 120 minutes.
Primary Respiratory quotient Respiratory quotient will be determined with indirect calorimetry. Change from baseline to 30 minutes and 120 minutes.
Primary Blood pressure Systolic and diastolic blood pressures will be determined with blood pressure device (Omron M3) Change from baseline to 30 minutes and 120 minutes.
See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT05997303 - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT03918486 - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed NCT03410342 - The Effects of Types of Fruits and Vegetables on Vascular Function N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT03294928 - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03997461 - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device N/A
Completed NCT03290716 - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China N/A
Recruiting NCT05196048 - Blood Pressure Sensor of Watch-type Device With ECG Technology
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Completed NCT02924454 - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol. Phase 4
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Active, not recruiting NCT02670967 - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials N/A
Completed NCT02239744 - Intervention Study on the Health Impact of Air Filters in Chinese Adults N/A
Completed NCT02271633 - Nitrate Supplementation; Source Phase 4