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A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT04701463
Recruitment Status : Completed
First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Azienda di Servizi alla Persona di Pavia

Study Description
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Brief Summary:
The use of dietary amino acids has been explored for therapeutic and safety intervention of obesity and obesity-induced dysfunction. In particular, 3 molecules have been shown to be effective both in the animal model and in humans, in promoting the loss of fat mass, specifically visceral adipose tissue, and in maintaining free fat mass: arginine, glutamine and leucine (and its metabolite beta hydroxy methyl butyrate, HMB). The aim of this study was to evaluate the efficacy in terms of fat mass, in particular Visceral Adipose Tissue reduction, as primary end point, in obese patients following the administration of specific food for special medical purposes (FSMP) for muscle recovery, consisting of arginine, glutamine and HMB. The secondary end point is the evaluation of skin state, by a validate self-reported questionnaire survey to assess skin, after 4- weeks intake of this FSMP.

Condition or disease Intervention/treatment Phase
Amino Acid Body Weight Changes Skin Manifestations Obesity Postmenopausal Disorder Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate Combination Product: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary Postmenopausal Women
Actual Study Start Date : January 15, 2020
Actual Primary Completion Date : November 3, 2020
Actual Study Completion Date : November 25, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate
2 daily sachets (mid morning and mid afternoon) of an oral dietary supplement with L-glutamine and L-arginine and calcium beta-hydroxy-beta-methylbutyrate
Placebo Comparator: Placebo Combination Product: Placebo
Isocaloric formula


Outcome Measures
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Primary Outcome Measures :
  1. Changes on Visceral Adipose Tissue [ Time Frame: Baseline / 30 days ]
    Evaluation of Visceral Adipose Tissue (g)


Secondary Outcome Measures :
  1. Changes on Body Composition [ Time Frame: Baseline / 30 days ]
    Evaluation of fat mass and fat free mass (g)

  2. Changes on Metabolic parameters [ Time Frame: Baseline / 30 days ]
    Evaluation of Fasting blood glucose (mg/dl), total cholesterol (mg/dl), low-density lipoprotein-cholesterol (mg/dl), high-density lipoprotein-cholesterol (mg/dl) and triglyceride levels (mg/dl)

  3. Changes on Metabolic parameters [ Time Frame: Baseline / 30 days ]
    Evaluation of insulin (mcIU/mL)

  4. Changes on Metabolic parameters [ Time Frame: Baseline / 30 days ]
    Evaluation of insulin resistance (HOMA index)

  5. Changes on anthropometric measurements [ Time Frame: Baseline / 30 days ]
    Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2)

  6. Changes on anthropometric measurements [ Time Frame: Baseline / 30 days ]
    Evaluation of waist circumference (cm)

  7. Changes on skin condition [ Time Frame: Baseline / 30 days ]
    Administration of a questionnaire survey with a point evaluation scale from 0 to 5 (Oe et al, 2017). For the skin luster and suppleness, one is the worst and five is the best. For the wrinkles, one is least wrinkles; not worry, and five is most wrinkles; most care.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopause
  • Obesity (I class) or overweight

Exclusion Criteria:

  • Taking any medication
  • Having liver, renal and thyroid disease
  • Smoking
  • Drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Contacts and Locations
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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): NCT04701463


Locations
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Italy
Azienda di Servizi alla Persona
Pavia, Italy, 27100
Sponsors and Collaborators
Azienda di Servizi alla Persona di Pavia
More Information
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Responsible Party: Azienda di Servizi alla Persona di Pavia
ClinicalTrials.gov Identifier: NCT04701463    
Other Study ID Numbers: 0912/14122018
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
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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Overweight
Body Weight
Body Weight Changes
Skin Manifestations
 Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs