Metabolic Impact of Dietary Protein Supplementation in Surgical Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

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
    

Detailed description: 
      The goal of this proposal is to study the effect of dietary protein supplementation (PRO-S)
      during surgical weight loss, on nitrogen balance, energy expenditure, body composition of
      weight loss, and satiety. The overall goal is to provide evidence-based data on optimal
      levels of protein supplementation after surgical weight loss by gastric bypass (GBP), a
      restrictive and malabsorptive procedure, or by vertical sleeve gastrectomy (VSG), a purely
      restrictive procedure.

      We propose a prospective randomized controlled trial (RCT), in which, patients undergoing
      either GBP or VSG will be allocated to standard PRO-S recommendation ("standard care"
      according to the American Society for Metabolic and Bariatric Surgery Guidelines) or high
      supplementation. We will compare 4 groups of subjects:

        -  Group 1: GBP Standard PRO-S (0.8g protein/kg ideal body weight (IBW)/day

        -  Group 2: GBP High PRO-S (1.2g protein/ kg ideal body weight (IBW)/ day)

        -  Group 3: VSG Standard PRO-S (0.8g protein/kg ideal body weight (IBW)/day

        -  Group 4: VSG High PRO-S (1.2g protein/ kg ideal body weight (IBW)/ day)

      AIM#1: Measure total body nitrogen balance (NB) to assess adequacy of levels of protein
      intake and protein absorption.

      AIM#2: Measure the effect PRO-S on lean body mass (LBM), and resting energy expenditure
      (REE).

      AIM#3: Measure the effect of PRO-S on satiety. Hypothesis 3.1: Patients in the High PRO-S
      group will experience higher levels of perceived satiety compared with patients in the
      standard PRO-S group.

      AIM #4: Study adherence to protein supplementation. Hypothesis : Adherence will be greater in
      the Standard PRO-S group.

      Background and Significance The obesity epidemic has grown rapidly in the United States, and
      is associated with increased morbidity and mortality rates. Although preventive measures are
      needed to solve the obesity epidemic in the long-term, bariatric surgery has become a popular
      and effective treatment of severe obesity. Obesity and its co-morbidities, including type 2
      diabetes (T2DM), have a high health care cost2. The cost is even greater for severe obesity
      (BMI≥40 kg/m2).

      Protein (PRO) malnutrition after bariatric surgery (BS) Bariatric surgery (BS) has emerged as
      the most effective treatment for severe obesity. Gastric bypass surgery (GBP) results in
      large weight loss with normalization of metabolic functions, including T2DM remission in
      ~60-80% of cases. Weight loss is very significant (~40-50kg). The rate of weight loss is
      rapid during the first year after surgery. Surgical weight loss can be associated with
      vitamin, mineral, and protein deficiencies. PRO malnutrition, remains the most severe
      nutritional complication associated with malabsorptive surgical procedures. The prevalence of
      protein malnutrition after malabsorptive BS procedures varies between 3 to 18% and is
      associated with the length of the bypassed segment. The US recommended dietary allowance
      (RDA) for protein is ~50 g/d for healthy normal weight adults. Experts and clinicians
      recommend ~70 g/d of protein during low-calorie diets or 60 g/day (standard) and 120 g/day
      (high) in the earlier months after BS. However, there is little evidence-based data to
      support these recommendations. In spite of the absence of level 1 data on types and amount of
      protein recommendations, the American Society for Metabolic Surgery and BS's website has 14
      links for commercial nutrition supplements14. In this study, we aim to study protein
      absorption and adequacy of protein intake by nitrogen balance in patients following standard
      and high PRO-S following BS.

      Effects of dietary proteins Dietary PRO-S and amino acids (AA) are important modulators of
      body weight by affecting various determinants of body weight regulation: satiety,
      thermogenesis, energy efficiency and body composition. During energy restriction, sustaining
      protein intake at the level of requirement (0.8g protein/kg ideal body weight (IBW)/ day)
      appears to be sufficient to induce body weight loss while preserving fat free mass (FFM).
      Protein intake above requirements (1.2g protein/Kg IBW/ day) results in a greater decrease in
      fat mass and preservation of FFM, but has no effect on body weight loss.

      Nitrogen balance (NB) study The NB method is classically used to determine adequate protein
      intakes and to measure whole body protein balance in response to nutritional interventions.
      Prolonged negative nitrogen balance should not be sustained for long periods due its negative
      impact on overall health.

      Risk of decreased lean body mass (LBM) and resting energy expenditure (REE) with surgical
      weight loss BS results in large weight losses (30-50kg), with both fat mass (FML) and LBM
      losses. Our previous observational studies aiming to evaluate the relationship between
      protein intake and loss of LBM following BS have shown that protein intake > 60g/ day is
      associated with better maintenance of LBM after BS. LBM is the main determinant of REE,
      explaining 75% of the REE variance with REE being the largest component of 24-h energy
      expenditure (EE). Reduced EE may trigger weight regain in this population. High PRO-S diets
      may also benefit this population by increasing EE while preventing LBM loss. Increased EE
      from dietary protein is attributed to an enhanced thermic effect (23-30%) compared to
      carbohydrates (5-10%) or lipids (2-3%).

      Dietary protein intake and satiety High-protein intake increases satiety despite energy
      restriction. Proposed mechanisms are as follows: a ketogenic state, relatively elevated
      plasma amino acid (AA) levels, and anorexigenic hormone concentrations feedback on the
      central nervous system to prolong the duration before one feels hunger for the next meal
      (satiety) such as, Peptide YY, Glucagon-Like Peptide -1 and cholecystokinin produced in
      response to peripheral and central detection of amino acid, and decreased levels of the
      orexigenic hormone ghrelin.

      Protein supplementation and adherence Low protein intake after BS has been reported. PRO-S
      has always been recommended after BS but its feasibility has not been well addressed in any
      RCT. We will study adherence to PRO-S. Increasing adherence with dietary recommendation is
      challenging, but may represent a key strategy to improve the clinical nutritional treatment
      and outcomes after BS.
    

Intervention name(s): GBP-SPS; GBP-HPS; VSG-SPS; VSG-HPS
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bariatric Surgery; Nitrogen Balance; Body composition; Protein supplementation; Satiety; Adherence