Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators

Cardiovascular Diseases Clinical Trial

Official title:

Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906771
• Other study ID #: UA-2023-05-08
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: University of Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Composition
• Body Weight
• Cardiovascular Diseases
• Diet, Mediterranean

Intervention

Dietary Supplement:
• Metabolaid(R)
The participating subjects will have to follow the intake of the nutraceutical for 3 months, as well as attend the stipulated visits. Participants will be given a register to control their daily intake of the nutraceutical. They should not change their daily habits. The nutraceutical has been elaborated by Monteloeder, S.L. It is a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves. The dose that the participants of the experimental group will receive will be 300mg plus 20mg of microcrystalline cellulose. The product is presented in an unflavored capsule, it is a reddish-brown powder with a characteristic odor and a slightly bitter taste. The manufacturing date of the product was 01/12/2022 and the expiration date was 30/11/2024.
• Nutraceutical placebo
The participating subjects will have to follow the intake of the nutraceutical for 3 months, as well as attend the stipulated visits. Participants will be given a register to control their daily intake of the nutraceutical. They should not change their daily habits. Nutraceutical placebo contains microcystalline cellulose (185mg) and maltodextrin (185mg).

Locations

Country	Name	City	State
Spain	Alejandro Martínez Rodríguez	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WEIGHT	The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).	12 weeks
Primary	HEIGHT	The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).	12 weeks
Primary	BLOOD PREASURE	Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.	12 weeks
Primary	FAT MASS	Assessment of body composition by DXA and bioimpedance to obtain fat mass results.	12 weeks
Primary	HEART RATE	Measurement of heart rate with a digital tensiometer.	12 weeks
Primary	SATIETY	Scores will be obtained through validated questionnaires for the study of satiety of the participating subjects.	12 weeks
Primary	BLOOD CHOLESTEROL LEVEL	Cholesterol blood values will be obtained using the flexible and portable accutrend® plus	12 weeks
Primary	TRIGLICERIDES	Triglicerides blood values will be obtained using the flexible and portable accutrend® plus	12 weeks
Primary	BLOOD GLUCOSE LEVEL	Glucose blood values will be obtained using the flexible and portable accutrend® plus	12 weeks