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Effect of Metabolaid® on AMPK Activation for Weight Loss

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Metabolaid®
Placebo
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

36 Years - 69 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad Miguel Hernandez de Elche

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Control

Dietetic Supplement Group

Arm Description

2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks

2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks

Outcomes

Primary Outcome Measures

Changes in body Weight, using a weight scale
In Kg

Secondary Outcome Measures

Height, using measuring tape
In cm
BMI, calculated based on Weight and Height
in kg/m^2
Waist Circumference, using a measuring tape
in kg/m^2
Glucose
Blood Sampling in Fasting conditions, in mg/dl
Tryglicerides
Blood Sampling in Fasting conditions, in mg/dl
LDL Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
HDL Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Total Cholesterol
Blood Sampling in Fasting conditions, in mg/dl
Blood Pressure
Single Blood Pressure measurements, using the Omron M6 Comfort device
Heart rate
Single Blood Pressure measurements, using the Omron M6 Comfort device

Full Information

First Posted
May 30, 2018
Last Updated
June 25, 2018
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Monteloeder SL
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1. Study Identification

Unique Protocol Identification Number
NCT03568877
Brief Title
Effect of Metabolaid® on AMPK Activation for Weight Loss
Official Title
Anti-obesity Effects of Metabolaid® With AMPK-activating Capacity in Overweight Subjects: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Monteloeder SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks
Arm Title
Dietetic Supplement Group
Arm Type
Experimental
Arm Description
2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Metabolaid®
Intervention Description
500 mg per day, in fasting conditions.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
500 mg per day, in fasting conditions.
Primary Outcome Measure Information:
Title
Changes in body Weight, using a weight scale
Description
In Kg
Time Frame
At the beginning, four weeks and end of the intervention, total eight weeks.
Secondary Outcome Measure Information:
Title
Height, using measuring tape
Description
In cm
Time Frame
At the beginning, four weeks and eight weeks
Title
BMI, calculated based on Weight and Height
Description
in kg/m^2
Time Frame
At the beginning, four weeks and eight weeks
Title
Waist Circumference, using a measuring tape
Description
in kg/m^2
Time Frame
At the beginning, four weeks and eight weeks
Title
Glucose
Description
Blood Sampling in Fasting conditions, in mg/dl
Time Frame
At the beginning, four weeks and eight weeks
Title
Tryglicerides
Description
Blood Sampling in Fasting conditions, in mg/dl
Time Frame
At the beginning, four weeks and eight weeks
Title
LDL Cholesterol
Description
Blood Sampling in Fasting conditions, in mg/dl
Time Frame
At the beginning, four weeks and eight weeks
Title
HDL Cholesterol
Description
Blood Sampling in Fasting conditions, in mg/dl
Time Frame
At the beginning, four weeks and eight weeks
Title
Total Cholesterol
Description
Blood Sampling in Fasting conditions, in mg/dl
Time Frame
At the beginning, four weeks and eight weeks
Title
Blood Pressure
Description
Single Blood Pressure measurements, using the Omron M6 Comfort device
Time Frame
At the beginning, four weeks and eight weeks
Title
Heart rate
Description
Single Blood Pressure measurements, using the Omron M6 Comfort device
Time Frame
At the beginning, four weeks and eight weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Universidad Miguel Hernandez de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Metabolaid® on AMPK Activation for Weight Loss

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