Ignite Creation Date:
2024-05-06 @ 3:20 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02269410
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2014-10-10
Brief Title:
Metabolic Impact of Dietary Protein Supplementation in Surgical Weight Loss
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Metabolic Impact of Dietary Protein Supplementation in Surgical Weight Loss II MIPS II
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIPS
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 08g kg ideal body weight IBW day appears to preserve fat free mass FFM during active WL PI above requirements 12g proteinKg IBW day results in favorable body composition changes with greater decrease in fat mass and preservation of FFM but without effecting WL Dietary PI 08gday 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 12g kg IBWday or standard- based current guidelines -PRO-S 08g kg IBWday 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 08g proteinkg ideal body weight IBWday
Group 2 GBP High PRO-S 12g protein kg ideal body weight IBW day
Group 3 VSG Standard PRO-S 08g proteinkg ideal body weight IBWday
Group 4 VSG High PRO-S 12g protein kg ideal body weight IBW day
AIM1 Measure total body nitrogen balance NB to assess adequacy of levels of protein intake and protein absorption
AIM2 Measure the effect PRO-S on lean body mass LBM and resting energy expenditure REE
AIM3 Measure the effect of PRO-S on satiety Hypothesis 31 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 BMI40 kgm2
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 gd for healthy normal weight adults Experts and clinicians recommend 70 gd of protein during low-calorie diets or 60 gday standard and 120 gday 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 BSs 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 08g proteinkg ideal body weight IBW day appears to be sufficient to induce body weight loss while preserving fat free mass FFM Protein intake above requirements 12g proteinKg 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
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 08g proteinkg ideal body weight IBWday
Group 2 GBP High PRO-S 12g protein kg ideal body weight IBW day
Group 3 VSG Standard PRO-S 08g proteinkg ideal body weight IBWday
Group 4 VSG High PRO-S 12g protein kg ideal body weight IBW day
AIM1 Measure total body nitrogen balance NB to assess adequacy of levels of protein intake and protein absorption
AIM2 Measure the effect PRO-S on lean body mass LBM and resting energy expenditure REE
AIM3 Measure the effect of PRO-S on satiety Hypothesis 31 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 BMI40 kgm2
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 gd for healthy normal weight adults Experts and clinicians recommend 70 gd of protein during low-calorie diets or 60 gday standard and 120 gday 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 BSs 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 08g proteinkg ideal body weight IBW day appears to be sufficient to induce body weight loss while preserving fat free mass FFM Protein intake above requirements 12g proteinKg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None