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Effect of Metabolaid® on AMPK Activation for Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03568877
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Monteloeder SL
Information provided by (Responsible Party):
María Herranz-Lopez, Universidad Miguel Hernandez de Elche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Metabolaid® Dietary Supplement: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Anti-obesity Effects of Metabolaid® With AMPK-activating Capacity in Overweight Subjects: A Randomized Controlled Trial
Actual Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Control
2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks
Dietary Supplement: Placebo
500 mg per day, in fasting conditions.

Experimental: Dietetic Supplement Group
2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks
Dietary Supplement: Metabolaid®
500 mg per day, in fasting conditions.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   36 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568877


Locations
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Spain
Universidad Miguel Hernandez de Elche
Elche, Alicante, Spain, 03202
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
Monteloeder SL
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Responsible Party: María Herranz-Lopez, Assistant Professor, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT03568877    
Other Study ID Numbers: UniversidadMHE_Met AMPK
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases