Amino AcidNCT04701463
A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women
A study testing L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate in people with Amino Acid and Body Weight Changes, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amino Acid, Body Weight Changes, Skin Manifestations
- What is being tested?
- L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2020to 25 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopause
- Obesity (I class) or overweight
Who cannot join
- Taking any medication
- Having liver, renal and thyroid disease
- Smoking
- Drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary 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.
- Being tested
- L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate, Placebo
- Medical subject headings
- Body Weight Changes, Skin Manifestations, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrateDietary 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
PlaceboCombination product
Isocaloric formula
| Study group | Role | What they receive |
|---|---|---|
| L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement | Experimental | Not described Receives: Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate |
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on Visceral Adipose Tissue
Evaluation of Visceral Adipose Tissue (g)
Measured: Baseline / 30 days
Secondary outcomes (7)
Changes on Body Composition
Evaluation of fat mass and fat free mass (g)
Measured: Baseline / 30 days
Changes on Metabolic parameters
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)
Measured: Baseline / 30 days
Changes on Metabolic parameters
Evaluation of insulin (mcIU/mL)
Measured: Baseline / 30 days
Changes on Metabolic parameters
Evaluation of insulin resistance (HOMA index)
Measured: Baseline / 30 days
Changes on anthropometric measurements
Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2)
Measured: Baseline / 30 days
Changes on anthropometric measurements
Evaluation of waist circumference (cm)
Measured: Baseline / 30 days
Changes on skin condition
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.
Measured: Baseline / 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start15 Jan 2020
- Primary completion3 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701463
- Sponsor's protocol ID
- 0912/14122018
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04701463
- Acronym / sponsor ID
- 0912/14122018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement | Experimental | Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate |
| Placebo | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopause
- Obesity (I class) or overweight
Key exclusion criteria (4 listed)
- Taking any medication
- Having liver, renal and thyroid disease
- Smoking
- Drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate2 daily sachets (mid morning and mid afternoon) of an oral dietary supplement with L-glutamine and L-arginine and calcium beta-hydroxy-beta-methylbutyrate | Dietary supplement | L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement |
| PlaceboIsocaloric formula | Combination product | Placebo |
Primary outcome
Changes on Visceral Adipose Tissue
Time frame: Baseline / 30 days
Evaluation of Visceral Adipose Tissue (g)
7 secondary outcomes
Changes on Body Composition
Time frame: Baseline / 30 days
Changes on Metabolic parameters
Time frame: Baseline / 30 days
Changes on Metabolic parameters
Time frame: Baseline / 30 days
Changes on Metabolic parameters
Time frame: Baseline / 30 days
Changes on anthropometric measurements
Time frame: Baseline / 30 days
Changes on anthropometric measurements
Time frame: Baseline / 30 days
Changes on skin condition
Time frame: Baseline / 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate in people with Amino Acid and Body Weight Changes, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on Visceral Adipose Tissue (time frame: Baseline / 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.