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Trial · NCT03784495

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Total Fat Mass and Total Free Fat Mass (DXA)0, 30 days
Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured by DXA, using a Lunar Prodigy DXA (GE Medical Systems, Waukesha, WI). Free Fat mass and Fat mass of specific body regions were measured in kilograms.
PrimaryChange in Handgrip Strenght0, 30 days
Handgrip strength assessed using a Jamar dynamometer adhering to the standardized protocol recommended by the American Society of Hand Therapists. A weak handgrip was defined as \<30 kg for men and \<20 kg for women, based on the average value of the two handgrip measurements of the dominant hand
SecondaryHeightAt baseline (0)Height measured in meters
SecondaryChange in Body Weight0, 30 daysBody Weight measured in kilograms
SecondaryChange in serum proteins0, 30 daysSerum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl
SecondaryChange in blood lipids (total cholesterol and triglycerides)0, 30 daysBlood lipids (total cholesterol and triglycerides)were measured by automatic biochemical analyzer. They were reported as mg/dl
SecondaryChange in High-sensitivity C-reactive protein (CRP)0, 30 daysHigh-sensitivity C-reactive protein (CRP) was expressed in mg/dl.
SecondaryChange in erythrocyte sedimentation rate (ESR)0, 30 daysErythrocyte sedimentation rate (ESR) was expressed in mm/hr.
SecondaryChange in glycaemia0, 30 daysglycemia was expressed in mg/dl
SecondaryChange in Mini Nutritional Assessment (MNA)0, 30 days
A mini nutritional assessment (MNA) was performed for all participants. The MNA uses 18 questions regarding simple measurements and a brief questionnaire involving an anthropometric assessment (weight, height and weight loss), a general assessment (lifestyle, medication and mobility), and a dietary assessment (number of meals, food and fluid intake, self-assessment of eating autonomy and self-perception of health and nutrition). Every answer give up to a maximum of 3 points. The sum of all points gives the total MNA. A maximum of 30 points can be achieved. A score of ≥ 24 points describes a well-nourished status. A score of 17 to 23.5 points indicates a risk of malnutrition, while less than 17 points indicates malnutrition.
SecondaryChange in dietary intakeMeasures taken at day 1,2,3 and at day 28,29,30A trained dietitian used a calibrated dietetic spring scale to weigh all foods served and returned for 3 consecutive days at the beginning and end of the study

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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