CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
GBP-SPS +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02269410
NCT02269410N/ACompleted

Metabolic Impact of Dietary Protein Supplementation in Surgical Weight Loss II (MIPS II)

Columbia University·interventional·Posted Oct 21, 2014·Updated Jul 19, 2017

In Brief

A clinical study evaluating GBP-SPS, GBP-HPS, and 2 other interventions for Obesity. Completed, enrolled 6 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 21, 2014
Enrollment StartNov 1, 2014
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.7 years ago

Interventions

GBP-SPSdietary

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-HPSdietary

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-SPSdietary

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-HPSdietary

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.