Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators
- Conditions
- Diet, MediterraneanAntioxidant EffectBody CompositionCardiovascular DiseasesDensitometryBody Weight
- Interventions
- Dietary Supplement: Metabolaid(R)Dietary Supplement: Nutraceutical placebo
- Registration Number
- NCT05906771
- Lead Sponsor
- University of Alicante
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Elderly (< 18 years)
- Overweight (body mass index 25-29.9 kg/m2)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description EXPERIMENTAL GROUP Metabolaid(R) Intake of natural herbal dietary supplement composed of a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves. CONTROL GROUP Nutraceutical placebo Nutraceutical placebo intake group
- Primary Outcome Measures
Name Time Method WEIGHT 12 weeks The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
HEIGHT 12 weeks The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
HEART RATE 12 weeks Measurement of heart rate with a digital tensiometer.
BLOOD PREASURE 12 weeks Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
FAT MASS 12 weeks Assessment of body composition by DXA and bioimpedance to obtain fat mass results.
TRIGLICERIDES 12 weeks Triglicerides blood values will be obtained using the flexible and portable accutrend® plus
BLOOD GLUCOSE LEVEL 12 weeks Glucose blood values will be obtained using the flexible and portable accutrend® plus
SATIETY 12 weeks Scores will be obtained through validated questionnaires for the study of satiety of the participating subjects.
BLOOD CHOLESTEROL LEVEL 12 weeks Cholesterol blood values will be obtained using the flexible and portable accutrend® plus
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alejandro Martínez Rodríguez
🇪🇸Elche, Alicante, Spain