Clinical trial NCT05906771: Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators
Official title: Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Mediterranean
Antioxidant Effect
Body Weight
Cardiovascular Diseases
Densitometry
Body Composition
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Plant polyphenols have demonstrated the ability to ameliorate metabolic alterations induced by overweight and obesity, both in cellular and animal models, where most therapeutic approaches have failed. These have demonstrated the ability to improve appetite sensation, leading to improved body weight control, in addition to reducing fat accumulation and improving plasma glycemic and lipid profiles, as well as inflammatory process and vascular dysfunction. The plant polyphenols on which the extract to be studied will be based will be hibiscus and lemon verbena. A randomized controlled trial will be carried out in overweight or obese subjects from the province of Alicante. An electronic randomization will be carried out based on a two-branch design, therefore, there will be a control group (no intervention) and an experimental group (nutraceutical intake). Participants will have to ingest the nutraceutical for 3 months, as well as attend the agreed visits. Different satiety questionnaires, circulating parameters measured in capillaries (cholesterol, triglycerides and glucose), blood pressure and body composition measured by bone densitometry (DXA) will be collected. All variables will be measured at 4 different time points (baseline, 30 days, 60 days and 90 days). All these will be analyzed as a function of time; at the beginning and end of each intervention (intra-group analysis), as well as comparing the control group with the experimental group (inter-group analysis). A multidisciplinary team formed by physicians, nurses and nutritionists will be involved.


Eligibility criteria: Inclusion Criteria:

* Elderly (\< 18 years)
* Overweight (body mass index 25-29.9 kg/m2)

Exclusion Criteria:

* Pregnant or lactating subjects
* Who have participated in another study with similar characteristics in the last 3 months.
* Subjects with pathologies.
* Consumption of drugs and/or supplements
* Subjects with food intolerances/allergies.
* Subjects with muscle or joint injury.
* Subjects with impossibility to follow up the intervention.
* Refusal of informed consent

Primary outcomes:
measure: WEIGHT
timeFrame: 12 weeks
measure: HEIGHT
timeFrame: 12 weeks
measure: BLOOD PREASURE
timeFrame: 12 weeks
measure: FAT MASS
timeFrame: 12 weeks
measure: HEART RATE
timeFrame: 12 weeks
measure: SATIETY
timeFrame: 12 weeks
measure: BLOOD CHOLESTEROL LEVEL
timeFrame: 12 weeks
measure: TRIGLICERIDES
timeFrame: 12 weeks
measure: BLOOD GLUCOSE LEVEL
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Alejandro Martínez Rodríguez
state: Alicante
Study officials:
References: