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Completed

NCT Number: NCT05906771

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

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.

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Key information

Conditions

Diet, Mediterranean Antioxidant Effect Body Composition Body Weight Cardiovascular Diseases Densitometry Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alejandro Martínez Rodríguez

Elche, Alicante, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. WEIGHT

    Time frame: 12 weeks

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

  2. HEIGHT

    Time frame: 12 weeks

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

  3. BLOOD PREASURE

    Time frame: 12 weeks

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

  4. FAT MASS

    Time frame: 12 weeks

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

  5. HEART RATE

    Time frame: 12 weeks

    Measurement of heart rate with a digital tensiometer.

  6. SATIETY

    Time frame: 12 weeks

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

  7. BLOOD CHOLESTEROL LEVEL

    Time frame: 12 weeks

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

  8. TRIGLICERIDES

    Time frame: 12 weeks

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

  9. BLOOD GLUCOSE LEVEL

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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