Safety and Efficacy of the Short Daily Administration of Nitraria Retusa Extract in Overweight and Obese Participants. .
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Change in Total Cholesterol ( TC) levels
Study Overview
Brief Summary
The purpose of this randomized , double -blind clinical trial is to evaluate the efficacy and safety of a daily administration of Nitraria retusa extract in overweight and obese participants, during 10 days.
Detailed Description
Medicinal plants are widely used for their accessibility, safety and effectiveness and may be an excellent alternative strategy for developing future drugs with minor adverse effects. Several studies concerning the potential of bioactive components in plants and food products and their link to many diseases including, diabetes, cardiovascular disease and obesity.
Nitraria retusa is a salt-tolerant plant that belongs to the Nitrariaceae family. It is particularly distributed in Asia, China, North Africa, Russia and Europe.It grows in the southern part of Tunisia and it is locally known as Ghardaq. The leaves serve as supplement for the tea and are used as poultice. Fresh leaves of Nitraria retusa have been used in traditional medicine in case of poisoning, upset stomach, ulcers, gastritis, enteritis, heartburn, colitis, and colonic abdominal pain.
Moreover, anticancer, antioxidant, antiviral and antimicrobial activities of N. retusa have been reported .Several reports evinced that the leaf of Nitraria retusa contains high amounts of tannins, alkaloids, steroids and flavonoids, which could be responsible for its beneficial effects . Previous studies have demonstrated the effect of Nitraria retusa extract in obese mice against high fat diet through lowering glucose and triglycerides and the enhancement of the lipid metabolism in liver.
The purpose of this study was to evaluate the efficacy and safety of short daily administration of Nitraria retusa extract in lipid profile in overweight and obese patients, during 10 days.
This study will be carried out in 2 departments: the laboratory of biophysics of the Faculty of Medicine of Sousse and Endocrinology and diabetology of CHU Farhat Hached Sousse ,Tunisia. At day 0 and day 10 all the population will benifit of biological assessment which include:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males and females
- •age range of 18 and 75 years
- •BMI >25 kg/ m^2
Exclusion Criteria
- •Hypertension
- •Professional athletic
- •Pregnancy and breast feeding
- •Participant with medical or psychiatric disorder or chronic pathology,
- •Participant with eating disorder, food allergies.
- •Participant with a history of cardiovascular disease,
- •Participant with medication known to affect lipid metabolism,
- •Participant with major gastrointestinal problems.
Arms & Interventions
Experimental 1: low dose group
Tea infusion which contain 5 mg of flavonoids, (low dose of flavonoids treatment quantification) oral administration , once daily.
Intervention: Tea infusion (Dietary Supplement)
Experimental 2 : high dose group
Tea infusion which contain 20 mg of flavonoids, ( high dose of flavonoids Treatment quantification) oral administration , once daily .
Intervention: Tea infusion (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Total Cholesterol ( TC) levels
Time Frame: 10 days
To evaluate the efficacy of 20 mg of flavonoids in reducing TC levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration.
Change in Low Density Lipoprotein Cholesterol (LDL-C) levels
Time Frame: 10 days
To evaluate the efficacy of 20 mg of flavonoids in reducing LDL-C levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration
Change in serum Triglycerides (TG) levels
Time Frame: 10 days
To evaluate the efficacy of 20 mg of flavonoids in reducing serum TG compared with low dose group ( 5 mg of flavonoids) after 10 days administration .
Change in serum High Density Lipoprotein Cholesterol (HDL-C) levels
Time Frame: 10 days
To evaluate the efficacy of 20 mg of flavonoids in increasing HDL-C levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration
Secondary Outcomes
- no change from baseline in Red blood cells levels(10 days)
- no change from baseline in Platelets levels(10 days)
- no change from baseline in Alkaline phosphatase levels(10 days)
- no change from baseline in Aspartate aminotransferase levels.(10 days)
- no change from baseline in Alanine aminotransferase levels.(10 days)
- no change from baseline in gamma-glutamyltransferase levels.(10 days)
- no change from baseline in Albumin levels .(10 days)
- no change from baseline in total bilirubin levels(10 days)
- no change from baseline in direct bilirubin levels(10 days)
- no change from baseline in urea levels(10 days)
- no change from baseline in creatinine levels(10 days)
- no change from baseline in White blood cells levels(10 days)
- no change from baseline in Hemoglobin levels(10 days)
- no change from baseline in Hematocrit levels(10 days)
- no change from baseline in fasting blood glucose levels(10 days)
- no change from baseline in Hemodynamic indicators: heart rate and blood pressure : systolic blood pressure and diastolic blood pressure(10 days)
- Adverse events(10 days)
Investigators
Laouani Aicha
Assistant Professor PHD, Head of the common Services unit for Research , biophysics Laboratory
Faculty of Medicine, Sousse