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Completed

NCT Number: NCT04701463

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate

Dietary Supplement

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

Combination Product

Isocaloric formula

Primary outcomes

  1. Changes on Visceral Adipose Tissue

    Time frame: Baseline / 30 days

    Evaluation of Visceral Adipose Tissue (g)

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary Postmenopausal Women

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 8, 2021
Registry last updated
Jan 8, 2021

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.

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