Metabolic Impact of Dietary Protein Supplementation in Surgical Weight Loss

NCT02269410 | Completed

• 1 other identifier: AAAN6105
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

The obesity epidemic has grown rapidly in the United States, and is associated with increased morbidity and mortality rates. Bariatric surgery (BS) has emerged as the most effective treatment for severe obesity. Surgical weight loss (WL) is very significant (\~40-50kg) during the first 6-12 months after surgery. The adequate amount of dietary protein during the active period of surgical weight loss is not known. Dietary protein affects body weight regulation: satiety, thermogenesis, energy efficiency and body composition. During diet-induced energy-restriction, sustaining protein intake (PI) at the level of requirement (0.8g /kg ideal body weight (IBW)/ day) appears to preserve fat free mass (FFM) during active WL. PI above requirements (1.2g protein/Kg IBW/ day) results in favorable body composition changes, with greater decrease in fat mass and preservation of FFM, but without effecting WL. Dietary PI 0.8g/day has been associated with greater satiety and increased energy expenditure (EE) during calorie restriction. In this randomized prospective study, the investigators will evaluate the effect of PI on nitrogen balance, body composition, EE and satiety in 40 women undergoing either Gastric Bypass or Vertical Sleeve Gastrectomy, assigned to high protein supplementation (PRO-S), high PRO-S (1.2g /kg IBW/day) or standard- based current guidelines -PRO-S (0.8g /kg IBW/day). PRO-S will be supplied for 3 months after surgery. Outcome measures including nitrogen balance, body composition changes and satiety will be assessed at pre-surgery, and at 3, 6 and 12 months post-surgery. These results will help provide evidence-based data on safe and optimal levels of protein supplementation after BS

Conditions

Obesity

Keywords

Bariatric Surgery; Nitrogen Balance; Body composition; Protein supplementation; Satiety; Adherence

Outcome Measures

Primary Outcomes (3)

• Change in Nitrogen balance (NB)

  During inpatient stay. Nitrogen intake and output will be accurately monitored

  Change from baseline of NB at 3 months after surgery

• Change in Nitrogen balance (NB)

  During inpatient stay. Nitrogen intake and output will be accurately monitored

  Change form 3 month to 12 months

• Change in Nitrogen Balance

  During inpatient stay. Nitrogen intake and output will be accurately monitored

  Change from baselina to 12 months

Secondary Outcomes (3)

• Composite outcome measure consisting of Lean body mass (LBM), and resting energy expenditure (REE).

  0, 3 and 12 months after surgery

• Satiety scores

  0, 3 and 12 months

• Adherence score to protein supplementation.

  0, 3 and 12 months

Study Arms (4)

GBP-SPS

ACTIVE COMPARATOR

GBP Standard PRO-S (0.8g protein/kg ideal body weigh/day)

Dietary Supplement: GBP-SPS

GBP-HPS

EXPERIMENTAL

GBP High PRO-S (1.2g protein/ kg ideal body weight/ day)

Dietary Supplement: GBP-HPS

VSG-SPS

ACTIVE COMPARATOR

VSG Standard PRO-S (0.8g protein/kg ideal body weigh/ day)

Dietary Supplement: VSG-SPS

VSG-HPS

EXPERIMENTAL

VSG High PRO-S (1.2g protein/ kg ideal body weight/ day)

Dietary Supplement: VSG-HPS

Interventions

GBP-SPS DIETARY_SUPPLEMENT

Protein powder supplementation will be given to participants to add to regular foods during the dietary intervention phase until reach protein objectives based on randomization and during 12 weeks after Bariatric Surgery.

GBP-SPS

GBP-HPS DIETARY_SUPPLEMENT

Protein powder supplementation will be given to participants to add to regular foods during the dietary intervention phase until reach protein objectives based on randomization and during 12 weeks after Bariatric Surgery.

GBP-HPS

VSG-SPS DIETARY_SUPPLEMENT

Protein powder supplementation will be given to participants to add to regular foods during the dietary intervention phase until reach protein objectives based on randomization and during 12 weeks after Bariatric Surgery.

VSG-SPS

VSG-HPS DIETARY_SUPPLEMENT

Protein powder supplementation will be given to participants to add to regular foods during the dietary intervention phase until reach protein objectives based on randomization and during 12 weeks after Bariatric Surgery.

VSG-HPS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women scheduled to undergo either GBP or VSG.
• Ethnicity/gender: People of all race/ethnicity are eligible to participate, so that the study will reflect a diverse population.
• Non diabetic or diet controlled diabetic with no medication

You may not qualify if:

• Individuals who have a clinical history strongly suggestive of type 1 diabetes mellitus or T2DM will be excluded.
• Nitrogen retention disease such as renal or hepatic disease.
• Known malabsorption syndrome.
• Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.

Sponsors & Collaborators

• Columbia University: lead

Related Publications (30)

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  PMID: 27895003 DERIVED

Related Links

• Obesity Update 2012
• Unit States Department of agriculture

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Blandine Laferrere, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Xavier Pi-Sunyer, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of medicine

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07