Skip to main content
OpenTrials
Completed

NCT Number: NCT03568877

Effect of Metabolaid® on AMPK Activation for Weight Loss

The objective of this study was to establish a formulation, containing both Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) extracts (Metabolaid®) that had significant capacity to activate the AMPK-enzyme and to reduce triglyceride accumulation in the hypertrophied adipocyte model. Then, we assessed the efficacy of this combination in light-to-moderate-overweight subjects under risk of developing metabolic syndrome.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

36 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Miguel Hernandez de Elche

Elche, Alicante, 03202, Spain

About this study

AMP-activated protein kinase (AMPK) has been postulated as a molecular target in the amelioration of obesity-related diseases, where most therapeutic approaches have failed. Plant-polyphenols have shown the capacity to ameliorate obesity-induced metabolic disturbances. A combination of polyphenols (LC-HS) derived from Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) (lemon verbena) (Metabolaid®) was assessed for triglyceride accumulation and AMPK activation in the hypertrophied adipocyte model 3T3-L1. A dietary supplement containing 500 mg of LC-HS was evaluated in a double blind, placebo-controlled and randomized trial in 56 overweight subjects for two months. Anthropometric and circulating biochemical parameters were determined.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants with a body mass index (BMI) from 24 to 34 kg/m2

Exclusion criteria

  • total cholesterol lower than 200 mg/dL.
  • use of prescription medication for cholesterol or hypertension.
  • presence of any obesity-related pathology.
  • hormone replacement therapy.
  • consumption of antioxidant supplements/drugs.
  • alcohol addiction.
  • women who were pregnant or lactating.

Treatment and study plan

Metabolaid®

Dietary Supplement

500 mg per day, in fasting conditions.

Placebo

Dietary Supplement

500 mg per day, in fasting conditions.

Primary outcomes

  1. Changes in body Weight, using a weight scale

    Time frame: At the beginning, four weeks and end of the intervention, total eight weeks.

    In Kg

Secondary outcomes

  1. Height, using measuring tape

    Time frame: At the beginning, four weeks and eight weeks

    In cm

  2. BMI, calculated based on Weight and Height

    Time frame: At the beginning, four weeks and eight weeks

    in kg/m^2

  3. Waist Circumference, using a measuring tape

    Time frame: At the beginning, four weeks and eight weeks

    in kg/m^2

  4. Glucose

    Time frame: At the beginning, four weeks and eight weeks

    Blood Sampling in Fasting conditions, in mg/dl

  5. Tryglicerides

    Time frame: At the beginning, four weeks and eight weeks

    Blood Sampling in Fasting conditions, in mg/dl

  6. LDL Cholesterol

    Time frame: At the beginning, four weeks and eight weeks

    Blood Sampling in Fasting conditions, in mg/dl

  7. HDL Cholesterol

    Time frame: At the beginning, four weeks and eight weeks

    Blood Sampling in Fasting conditions, in mg/dl

  8. Total Cholesterol

    Time frame: At the beginning, four weeks and eight weeks

    Blood Sampling in Fasting conditions, in mg/dl

  9. Blood Pressure

    Time frame: At the beginning, four weeks and eight weeks

    Single Blood Pressure measurements, using the Omron M6 Comfort device

  10. Heart rate

    Time frame: At the beginning, four weeks and eight weeks

    Single Blood Pressure measurements, using the Omron M6 Comfort device

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Monteloeder SL

Registry information

Official study title

Anti-obesity Effects of Metabolaid® With AMPK-activating Capacity in Overweight Subjects: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2018
Registry last updated
Jun 27, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.