CClinicalTrials.gg
Active, not recruitingNCT07772908GPOWERUpdated Aug 19, 2026

Efficacy of Protein Supplementation in Preventing Muscle Mass Loss During the Weight Loss Process.

An interventional study of Experimental arm and Placebo in Prevention of Muscle Mass Loss, sponsored by Althaia S.A Industria Farmaceutica. Active, not recruiting at 1 site in Brazil. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Althaia S.A Industria Farmaceutica · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study summary

The objective of this study is to evaluate whether the supplement, combined with resistance training, prevents muscle mass loss during weight loss. The treatment will last four months and include clinical assessments, proper nutrition, and physical activity..

02

Conditions studied

  • Prevention of Muscle Mass Loss

Keywords

  • Supplement
  • Muscle mass
03

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants of both sexes aged between 25 and 60 years.
  • Ability to understand and accept participation in the study, indicated by signing the Informed Consent Form approved by the Ethics Committee.
  • Good health status, determined by the absence of significant findings in medical history, physical examination, laboratory tests, and vital sign measurements.
  • Agree to comply with the planned study procedures and attend visits.
  • Participants with the capacity and motivation to perform resistance training 3 to 5 times per week (150 to 200 minutes/week); - Participants with a body mass index (BMI) ≥ 27.0 kg/m².

Exclusion criteria

Exclusion Criteria:

  • Known allergy to components of the investigational product or placebo;
  • History of chronic use in the last 3 months or current use of medications or substances that affect the muscular system;
  • Current history of type 1 or 2 diabetes mellitus, gastrointestinal, cardiovascular, renal, or hepatic diseases, or malignant neoplasm, considered clinically significant at the physician's discretion.
  • Abuse of illicit drugs or alcohol, as clinically assessed by the investigator during screening.
  • Having participated in a clinical study in the last 12 months at the investigator's discretion.
  • Having any condition that prevents participation in the study at the investigator's discretion.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Dietary Supplement

    Dietary Supplement: Experimental arm Two doses, once daily. Other Name: Protein

    Dietary Supplement: Experimental arm

  • Placebo comparator
    Dietary Supplement: Placebo

    Dietary Supplement: Placebo Two doses, once daily Other Name:

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementExperimental arm

    Two doses, once a day.

    Also known as: Protein

  • Dietary supplementPlacebo

    Two doses, once daily

05

What researchers measure

Primary outcomes

  1. Change in fat-free mass relative

    Change in fat-free mass relative to baseline after 120 days of treatment, assessed by electrical bioimpedance.

    Time frame: 4 months

  2. Evaluation of the supplement's effect on preventing muscle mass loss during weight loss.

    Change in baseline mass compared to 120 days of treatment.

    Time frame: From the screening visit to the end of treatment - 120 days

06

Study locations

1 site
  • Althaia SA Indústria Farmacêutica
    Atibaia, São Paulo, Brazil
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07772908
Lead sponsor
Althaia S.A Industria Farmaceutica
Responsible party
Sponsor
First posted
Aug 19, 2026
Start date
Jun 9, 2026
Primary completion
Dec 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Aug 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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