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

NCT05906771 | Completed

• 1 other identifier: UA-2023-05-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Mediterranean; Antioxidant Effect; Body Weight; Cardiovascular Diseases; Densitometry; Body Composition

Outcome Measures

Primary Outcomes (9)

• WEIGHT

  The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).

  12 weeks

• HEIGHT

  The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).

  12 weeks

• BLOOD PREASURE

  Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.

  12 weeks

• FAT MASS

  Assessment of body composition by DXA and bioimpedance to obtain fat mass results.

  12 weeks

• HEART RATE

  Measurement of heart rate with a digital tensiometer.

  12 weeks

• SATIETY

  Scores will be obtained through validated questionnaires for the study of satiety of the participating subjects.

  12 weeks

• BLOOD CHOLESTEROL LEVEL

  Cholesterol blood values will be obtained using the flexible and portable accutrend® plus

  12 weeks

• TRIGLICERIDES

  Triglicerides blood values will be obtained using the flexible and portable accutrend® plus

  12 weeks

• BLOOD GLUCOSE LEVEL

  Glucose blood values will be obtained using the flexible and portable accutrend® plus

  12 weeks

Study Arms (2)

CONTROL GROUP

PLACEBO COMPARATOR

Nutraceutical placebo intake group

Dietary Supplement: Nutraceutical placebo

EXPERIMENTAL GROUP

EXPERIMENTAL

Intake of natural herbal dietary supplement composed of a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves.

Dietary Supplement: Metabolaid(R)

Interventions

Metabolaid(R) DIETARY_SUPPLEMENT

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.

EXPERIMENTAL GROUP

Nutraceutical placebo DIETARY_SUPPLEMENT

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).

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

Alejandro Martínez Rodríguez

Elche, Alicante, Spain

Location

MeSH Terms

Conditions

Body Weight; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)