NCT04771377

Brief Summary

Obesity is considered a chronic disease that increases the risk of developing diseases that reduce life expectancy. The treatment of obesity is complex. However, treatments based exclusively on dietary changes have not shown long-term efficacy especially in people with severe obesity. In contrast, in this group of people bariatric surgery (BS) has shown good long-term results in weight loss and maintenance. These changes are accompanied by significant improvements in health, improved quality of life, and reduced mortality. However, the changes in the digestive system created by BS and the high level of dietary restriction, affect the nutritional status and require a proper supplementation of vitamins and minerals during the follow-up. Intense weight loss during the first few months, coupled with an insufficient amount of protein in the diet, can lead to a loss of muscle mass. Excessive muscle loss during the short-term period can lead to functional repercussions (decreased strength and physical function) and reduced calories that the body burns daily. Naturally, this is especially important in people suffering from sarcopenia before BS, and it occurs more frequently in postmenopausal women. Despite this is known, specific protein intake recommendations after BS have not yet been defined based on scientific evidence. In this context, the first part of our proposal will assess the effect of two levels of protein supplementation: standard (S-PS) versus high (H-PS) on changes in a) body composition, b) energy expenditure, c) metabolic flexibility d) the physical condition during weight loss that follows BS. In addition, in patients with H-PS, the added effect of a physical exercise program, carried out with a personal trainer (professional of sports medicine trainer) virtually, will be evaluated. Protein supplementation and the virtual exercise program will be done during the 4 months following BS, and the results will be studied at 4, 8, and 12 months. Once the results have been defined, it is essential to transfer the recommendations to the real world. In a second part, and to achieve knowledge transfer to clinical practice, the investigators will explore the key elements that influence patient experience (XPA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

February 11, 2021

Last Update Submit

February 13, 2024

Conditions

Sarcopenic ObesityBariatric Surgery CandidateNutritional DeficiencyProtein Intolerance

Keywords

SarcopeniaPhysical trainingPostmenopausal Women

Outcome Measures

Primary Outcomes (28)

  • effect of PS and PA on Changes in fat mass and Fat free mass (kg)

    change from baseline in DEXA values

    4 months after BS

  • effect of PS and PA on Changes in fat mass and Fat free mass (kg)

    change from baseline in DEXA values

    8 months after BS

  • effect of PS and PA on Changes in fat mass and Fat free mass (kg)

    change from baseline in DEXA values

    12 months after BS

  • effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)

    change from baseline in estimated REE from indirect calorimety

    4 months after BS

  • effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)

    change from baseline in estimated REE from indirect calorimety

    8 months after BS

  • effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)

    change from baseline in estimated REE from indirect calorimety

    12 months after BS

  • Strength

    changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.

    4 months after BS

  • Strength

    changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.

    8 months after BS

  • Strength

    changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.

    12 months after BS

  • Functionality

    changes from baseline on sit and stand

    4 months after BS

  • Functionality

    changes from baseline on sit and stand

    8 months after BS

  • Functionality

    changes from baseline on sit and stand

    12 months after BS

  • Metabolic flexibility - oxidation of substrates: VO2 peak

    change in VO2 peak measured by Ergocard during half-effort test

    4 months after BS

  • Metabolic flexibility - oxidation of substrates: VO2 peak

    change in VO2 peak measured by Ergocard

    8 months after BS

  • Metabolic flexibility - oxidation of substrates: VO2 peak

    change in VO2 peak measured by Ergocard during half-effort test

    12 months after BS

  • Respiratory quotient

    change in RQ determined by Ergocard during half-effort test

    4 months after BS

  • Respiratory quotient

    change in RQ determined by Ergocard during half-effort test

    8 months after BS

  • Respiratory quotient

    change in RQ determined by Ergocard during half-effort test

    12 months after BS

  • Fat oxidation (FatMax) during during half-effort test

    Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)

    4 months after BS

  • Fat oxidation (FatMax) during during half-effort test

    Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)

    8 months after BS

  • Fat oxidation (FatMax) during during half-effort test

    Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)

    12 months after BS

  • Adherence to PS (BCAA biomarker)

    serum change in BCAA (mcg)

    4 months after BS

  • Adherence to PS (BCAA biomarker)

    serum change in BCAA (mcg)

    8 months after BS

  • Adherence to PS (BCAA biomarker)

    serum change in BCAA (mcg)

    12 months after BS

  • Adherence to PS (urinary nitrogen 24hs.)

    Nitrogen (mg) values quantified in 24hs urine

    4 months after BS

  • Adherence to PS (urinary nitrogen 24hs.)

    Nitrogen (mg) values quantified in 24hs urine

    8 months after BS

  • Adherence to PS (urinary nitrogen 24hs.)

    Nitrogen (mg) values quantified in 24hs urine

    12 months after BS

  • Understand patients' priorities and the "painful points" of the care process. Explore the magnitude of these "painful points." This should make it possible to prioritize the areas to be evaluated. Test assessment tools

    identify by focus group patient reported outcomes by cualitative study

    12 months after BS

Secondary Outcomes (6)

  • Changes in BMI

    4 months after BS

  • Changes in BMI

    8 months after BS

  • Changes in BMI

    12 months after BS

  • Insulin sensitivity (HOMA-IR)

    4 months after BS

  • Insulin sensitivity (HOMA-IR)

    8 months after BS

  • +1 more secondary outcomes

Study Arms (3)

standard protein supplementation (SPS)

EXPERIMENTAL

0.8g protein/ IBW/ day

Dietary Supplement: Protein Supplementation

High protein supplementation (HPS)

EXPERIMENTAL

1.2g protein/ IBW/ day

Dietary Supplement: Protein Supplementation

HPS + PA

EXPERIMENTAL

1.2g protein/ IBW/ day + PA 3 times a week/ 12 weeks

Dietary Supplement: Protein Supplementation

Interventions

Protein SupplementationDIETARY_SUPPLEMENT

protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT

Also known as: Physical training, standard protein supplementation
HPS + PAHigh protein supplementation (HPS)standard protein supplementation (SPS)

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study will only include women. The difference in muscle mass and strength justifies the need for this limitation. In addition, women account for 80% of CB cases in our Hospital and in the vast majority of literature series. Given that muscle mass loss and risk of sarcopenia are typical of older adults, our study (focused on the prevention and / or delay of the onset of sarcopenia) targets women over the age of 45 a first CB in our center. Although the results of this study will only be valid for this group, the resulting nutritional and lifestyle recommendations will be relevant as women are the majority in the use of CB. Addressing this goal in men would require a different protocol.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women ≥45 years of age who meet CB criteria: Body mass index (BMI) ≥40.0 kg / m2 or between 35.0 and 39.9 kg / m2 with comorbidities (metabolic diseases, cardiorespiratory diseases), sedentary lack of regular physical activity: \<30 minutes / day and \<3 days / week).

You may not qualify if:

  • presence of severe joint disease, severe liver disease, history of cardiovascular event or known heart disease, renal failure (defined as a FG \<30 ml / min), type 1 or type 2 diabetes with HbA1c\> 10%, being treated with drugs that may affect body composition (such as corticosteroids), exercise muscle strength-endurance regularly (more than 2 times / week), have previously undergone obesity surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

MalnutritionSarcopenia

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Violeta L Moizé, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2:2:1.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 25, 2021

Study Start

November 10, 2020

Primary Completion

January 10, 2023

Study Completion

June 30, 2023

Last Updated

February 14, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)