An interventional study of Metabolaid(R) and Nutraceutical placebo in Diet, Mediterranean, Antioxidant Effect and Body Weight, sponsored by University of Alicante. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Alicante · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
Nutraceutical placebo intake group
Dietary Supplement: Nutraceutical placebo
Intake of natural herbal dietary supplement composed of a combination of Hibiscus sabdariffa flowers and Lippia citriodora leaves.
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.
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).
WEIGHT
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
Time frame: 12 weeks
HEIGHT
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
Time frame: 12 weeks
BLOOD PREASURE
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Time frame: 12 weeks
FAT MASS
Assessment of body composition by DXA and bioimpedance to obtain fat mass results.
Time frame: 12 weeks
HEART RATE
Measurement of heart rate with a digital tensiometer.
Time frame: 12 weeks
SATIETY
Scores will be obtained through validated questionnaires for the study of satiety of the participating subjects.
Time frame: 12 weeks
BLOOD CHOLESTEROL LEVEL
Cholesterol blood values will be obtained using the flexible and portable accutrend® plus
Time frame: 12 weeks
TRIGLICERIDES
Triglicerides blood values will be obtained using the flexible and portable accutrend® plus
Time frame: 12 weeks
BLOOD GLUCOSE LEVEL
Glucose blood values will be obtained using the flexible and portable accutrend® plus
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Alicante