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Effects of a New Metabolic Conditioning Supplement on Perioperative Metabolic Stress and Clinical Outcomes: A Randomized, Placebo-Controlled Trial.

ABSTRACT: BACKGROUND:Insulin resistance is a measure of metabolic stress in the perioperative period. Before now, no clinical trial has determined the summative effects of glutamine, L-carnitine, and antioxidants as metabolic conditioning supplements in the perioperative period. OBJECTIVES:The purpose of this study was to determine the effects of a new conditioning supplement on perioperative metabolic stress and clinical outcomes in non-diabetic patients. PATIENTS AND METHODS:In this randomized controlled trial, 89 non-diabetic patients scheduled for coronary artery bypass grafting, with ejection fractions above 30%, were selected. Using the balanced block randomization method, the patients were allocated to one of four study arms: 1) SP (supplement/placebo): supplement seven days before and placebo 30 days after the surgery; 2) PS: placebo before and supplement after the surgery; 3) SS: supplement before and after the surgery; and 4) PP: placebo before and after the surgery. The supplement was composed of glutamine, L-carnitine, vitamin C, vitamin E, and selenium, which was manufactured for the first time by this research team. Five blood samples were drawn: seven days preoperatively, at the entrance to the operating room, while leaving the operating room, seven days postoperatively, and 30 days postoperatively. Levels of glucose, insulin, and HbA1c were measured in blood samples. Insulin resistance and sensitivity were calculated using a formula. Surgical complications were assessed 30 days postoperatively. Data analysis was done using one-way ANOVA, the Chi-square test, and a general linear model repeated-measures analysis with Bonferroni adjustment. RESULTS:Blood glucose levels were increased postoperatively in the four groups (< 0.001), but a significantly higher increase occurred in the PP group compared to the SP (0.027), PS (0.026), and SS (0.004) groups. The superficial wound infection rate was significantly different between the four groups (0.021): 26.08% in PP, 9.09% in SP, 4.54% in PS, and 0% in SS. CONCLUSIONS:Our new metabolic conditioning supplement, whether given pre- or postoperatively, led to better perioperative glycemic control and decreased postsurgical wound infections in non-diabetic patients.

SUBMITTER: Akbarzadeh M

PROVIDER: S-EPMC4752820 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Effects of a New Metabolic Conditioning Supplement on Perioperative Metabolic Stress and Clinical Outcomes: A Randomized, Placebo-Controlled Trial.

Akbarzadeh Marzieh M Akbarzadeh Marzieh M Eftekhari Mohammad Hassan MH Shafa Masih M Alipour Shohreh S Hassanzadeh Jafar J

Iranian Red Crescent medical journal 20160109 1

<h4>Background</h4>Insulin resistance is a measure of metabolic stress in the perioperative period. Before now, no clinical trial has determined the summative effects of glutamine, L-carnitine, and antioxidants as metabolic conditioning supplements in the perioperative period.<h4>Objectives</h4>The purpose of this study was to determine the effects of a new conditioning supplement on perioperative metabolic stress and clinical outcomes in non-diabetic patients.<h4>Patients and methods</h4>In thi ...[more]

PMID: 26889394

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Project description:Abstract Objectives To determine if greater weight loss and improvement in metabolic outcomes could be achieved with twice daily consumption of a proprietary supplement shake containing high protein and fiber (HPF) as compared to an isocaloric low protein, lower fiber placebo (P). Methods In an independently conducted randomized, double-blind, placebo-controlled, multi-center clinical trial, healthy overweight and obese adults (n = 206, BMI 27–35 kg/m2, 70% Female) were equally assigned to HPF or P. All participants were instructed to follow a 500-calorie deficit diet from estimated daily energy requirements using a dietary exchange program and were asked to consume HPF or P 30 min before breakfast and lunch for 12 weeks. The supplement was a commercially available product composed of protein, fruit, vegetable, and plant powders, as well as vitamins, minerals, pre-, and probiotics. Body weight, body composition, and blood samples were collected at days (D) 0 and 84. Statistics were conducted by ANCOVA or repeated measure ANCOVA modeling using sex and baseline values as covariates, with time and treatment as within- and between-subject variables, respectively. Per protocol analyses were included for the 133 adults who completed the study. Results Weight loss occurred throughout the study in both groups. HPF had greater weight loss at D 84 vs P (–4.0% vs −2.2% body weight, respectively; P < 0.05). Total cholesterol, LDL, and oxidized LDL decreased to a greater extent following HPF at D 84 (P < 0.05 vs D 0 and vs P), with no change in HDL cholesterol. The increase in serum adiponectin from D 0 to D 84 was greater in HPF vs P (P < 0.05) with no change in leptin. Percent body fat tended to decrease throughout the study in both groups (HPF: −1.44%, P: −1.27%; P = 0.056) with no differences between groups. There were no clinically relevant changes in assessed safety outcomes in either group. Conclusions A HPF supplement taken as a preload before breakfast and lunch improved weight loss and metabolic outcomes such as total, LDL and oxidized LDL cholesterol compared to a calorie-matched placebo. This study suggests nutrient factors other than calorie reduction alone influence the success of a weight loss regimen, potentially including nutrient density, protein and fiber content. This trial was registered at clinicaltrials.gov as NCT03057873. Funding Sources This study was funded by Beachbody, LLC.

Project description:Rhodiola crenulata (R) and Cordyceps sinensis (C) are commonly used herbs that promote health in traditional Chinese medicine. These two herbs have also been shown to exhibit anti-inflammation and antioxidant functions. Regular endurance training reveals potent endurance capacity, body composition improvement, and metabolic-related biomarker benefits. However, it is not known whether the combination of Rhodiola crenulata and Cordyceps sinensis (RC) supplementation during endurance training provides additive health benefits. The purpose of this study was to investigate the effects of 8-week endurance training plus RC supplementation on body composition, oxidative stress, and metabolic biomarkers in young sedentary adults. METHODS:Fourteen young sedentary adults (8M/6F) participated in this double-blind randomized controlled study. Participants were assigned to exercise training with placebo groups (PLA, n = 7, 4M/3F; age: 21.4 ± 0.4 years) and exercise training with the RC group (RC, 20 mg/kg/day; n = 7, 4M/3F; age: 21.7 ± 0.4 years). Both groups received identical exercise training for eight weeks. The body composition, circulating oxidative stress, and blood metabolic biomarkers were measured before and after the 8-week intervention. RESULTS:Improvement in body composition profiles were significantly greater in the RC group (body weight: p = 0.044, BMI: p = 0.003, upper extremity fat mass: p = 0.032, lower extremity muscle mass: p = 0.029, trunk fat mass: p = 0.011) compared to the PLA group after training. The blood lipid profile and systemic oxidative stress makers (thiobarbituric reactive substanceand total antioxidant capacity) did not differ between groups. Although endurance training markedly improved endurance capacity and glycemic control ability (i.e., fast blood glucose, insulin, and HOMA index), there were no differences in these variables between treatments. CONCLUSIONS:In this preliminary investigation, we demonstrated that an 8-week RC supplementation (20 mg/kg/day) faintly enhanced endurance training-induced positive adaptations in body composition in young sedentary individuals, whereas the blood lipid profile and systemic oxidative stress states were not altered after such intervention.

Project description:Various nutritional supplements are available over the counter, yet few have been investigated in randomized controlled trials. The rationale for using the specific mix of nutritional substances including collagen type II, hyaluronic acid, n-acetyl-glucosamine, bamboo extract, L-lysine, and vitamin C is the assumption that combining naturally occurring ingredients of the intervertebral disc would maintain spine function. This double-blinded, placebo-controlled randomized trial aimed to evaluate the efficacy of a nutraceutical supplement mix in the management of lumbar osteochondrosis. Fifty patients were randomly assigned to either the supplement or placebo group in a 1:1 ratio. Patient-Reported Outcome Measures (PROMs) included the Oswestry Disability Index (ODI), the visual analogue scale for pain (pVAS), short form-12 (SF-12) physical and mental component summary subscale scores (PCS and MCS, respectively), and global physical activity questionnaire (GPAQ). Magnetic resonance imaging (MRI) was used to evaluate degenerative changes of intervertebral discs (IVD) including Pfirrmann grades as well as three-dimensional (3D) volume measurements. Data were collected at baseline and after the 3-month intervention. None of the PROMs were significantly different between the supplement and placebo groups. Disc degeneration according to Pfirrmann classifications remained stable during the 3-month intervention in both groups. Despite no significance regarding the distribution of Pfirrmann grade changes (improvement, no change, worsening; p = 0.259), in the supplement group, one patient achieved a three-grade improvement, and worsening of Pfirrmann grades were only detected in the placebo group (9.1%). Furthermore, in-depth evaluations of MRIs showed significantly higher 3D-measured volume changes (increase) in the supplement (+740.3 ± 796.1 mm3) compared to lower 3D-measured volume changes (decrease) in the placebo group (-417.2 ± 875.0 mm3; p < 0.001). In conclusion, this multi-nutrient supplement might not only stabilize the progression of lumbar osteochondrosis, but it might also potentially even increase IVD volumes as detected on MRIs.

Dataset Information

Effects of a New Metabolic Conditioning Supplement on Perioperative Metabolic Stress and Clinical Outcomes: A Randomized, Placebo-Controlled Trial.

Publications

Effects of a New Metabolic Conditioning Supplement on Perioperative Metabolic Stress and Clinical Outcomes: A Randomized, Placebo-Controlled Trial.

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