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Completed

NCT Number: NCT01891591

Assessment of Nutritional Status After Gastric Bypass Surgery

This study is aimed at assessing how Roux-en-Y gastric bypass (RYGP) impacts on energy and nutrients' intake, energy expenditure, and nutritional status in obese patients. It will try quantitate energy and protein balance after RYGP, and to identify how RYGP effects the intake of various common dietary protein sources 16 female patients with BMI > 40 kg/m2 and on a waiting list for bariatric surgery will be included. The following measurements will be performed before, and 1, 3, 6, 12, and 36 months after RYGP

* body weight * body composition (bio impedancemetry) * basal metabolic rate (open circuit indirect calorimetry) * 24-hour urinary urea excretion * fasting blood chemistry * energy and macronutrient's intake (3-day dietary recall)

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Key information

Conditions

Obesity Body Weight Malnutrition Nutrition Disorders Nutritional Deficiencies Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinical Research Centre, CHUV

Lausanne, CH-1011, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18-65 years
  • gender: females
  • body mass index >35 kg/m2

Exclusion criteria

  • GI tract diseases
  • endocrine diseases

Treatment and study plan

Roux-en-Y gastric bypass (RYGP)

Procedure

Primary outcomes

  1. changes in daily dietary protein intake

    Time frame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery

    changes in 24-hour protein intake will be evaluated by 7-day food diary; portion size will be assessed with the use of photographs from the SU.VI.MAX study

Secondary outcomes

  1. changes in total energy intake

    Time frame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery

    changes in 24-hour energy intake will be evaluated by 7-day food diary; portion size will be assessed with the use of photographs from the SU.VI.MAX study

  2. changes in basal metabolic rate

    Time frame: measurements obtained baseline , and 3, 6, 12, 36 months after surgery

    BMR will be measured by indirect calorimetry over a 45-90 min period

  3. changes in total energy intake

    Time frame: measurements obtained baseline , and 1,3, 6, 12, 36 months after surgery

    Changes in daily total energy intake will be evaluated by 7-day food diary; portion size will be assessed with the use of photographs from the SU.VI.MAX study

Other outcomes

  1. changes in fasting, resting respiratory exchange ratio

    Time frame: measurements obtained baseline, and 3, 6, 12, and 36 months after RYGP

    measurement will be obtained by indirect calorimetry

  2. changes in 24-hour urinary urea excretion

    Time frame: Measurements obtained baseline , and 3, 6, 12, 36 months after RYGP

    24-hour urine collections

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Registry information

Official study title

Assessment of Nutritional Status and Vitamin Deficiencies in Obese Subjects After Gastric Bypass Surgery

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 3, 2013
Registry last updated
Jul 3, 2013

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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