scholarly journals A Nutrient-Dense Supplement Shake Improves Weight Loss and Metabolic Markers in Overweight Individuals: A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1638-1638
Author(s):  
Erin Glynn ◽  
Stephen Fleming ◽  
Heather Leidy ◽  
Michael Wilson
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Oxidized Ldl ◽  
Controlled Trial ◽  
Repeated Measure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Metabolic Outcomes ◽  
Nutrient Density ◽  
Plant Powders

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.

scholarly journals Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024065 ◽  
Author(s):  
Henrik Gudbergsen ◽  
Marius Henriksen ◽  
Eva Ejlersen Wæhrens ◽  
Anders Overgaard ◽  
Henning Bliddal ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Single Centre ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
Parallel Group ◽  
Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

scholarly journals The Effect of Antioxidant Supplementation in Patients with Tinnitus and Normal Hearing or Hearing Loss: A Randomized, Double-Blind, Placebo Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 3037 ◽  
Author(s):  
Anna I. Petridou ◽  
Eleftheria T. Zagora ◽  
Petros Petridis ◽  
George S. Korres ◽  
Maria Gazouli ◽  
...  
Keyword(s):  
Oxidized Ldl ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Antioxidant Compounds ◽  
Antioxidant Supplementation ◽  
Post Intervention ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Total Antioxidant ◽  
Post Measure

Tinnitus is the perception of sound in the absence of any external stimulus. Oxidative stress is possibly involved in its pathogenesis and a variety of antioxidant compounds have been studied as potential treatment approaches. The objective of the present study was to assess the effects of antioxidant supplementation in tinnitus patients. This is a randomized, double-blind, placebo-controlled clinical trial. Patients (N = 70) were randomly allocated to antioxidant supplementation (N = 35) or to placebo (N = 35) for a total of 3 months. Demographic, anthropometric, clinical, and nutritional data were collected. Serum total antioxidant capacity (TAC), oxidized LDL (oxLDL), and superoxide dismutase (SOD), tinnitus loudness, frequency, and minimum masking level (MML), and scores in Tinnitus Handicap Inventory questionnaire (THI), Tinnitus Functional Index (TFI), and Visual Analogue Scale (VAS) were evaluated at baseline and follow-up. Tinnitus loudness and MML significantly decreased from baseline to post measure (p < 0.001) only in the antioxidant group, the overall change being significantly different between the two groups post-intervention (p < 0.001). THI and VAS decreased only in the antioxidant group. Differences in changes in serum TAC, SOD, and oxLDL post-intervention were insignificant. In conclusion, antioxidant therapy seems to reduce the subjective discomfort and tinnitus intensity in tinnitus patients.

A phase 3, multicenter, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT).

2014 ◽  
Vol 32 (18_suppl) ◽  
pp. LBA6008-LBA6008 ◽  
Author(s):  
Martin Schlumberger ◽  
Makoto Tahara ◽  
Lori J. Wirth ◽  
Bruce Robinson ◽  
Marcia S. Brose ◽  
...  
Keyword(s):  
Weight Loss ◽  
Thyroid Cancer ◽  
Adverse Events ◽  
Differentiated Thyroid Cancer ◽  
Kinase Inhibitor ◽  
Controlled Trial ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

LBA6008 Background: Lenvatinib (LEN) is an oral tyrosine kinase inhibitor of the VEGFR1-3, FGFR1-4, PDGFRβ, RET, and KIT signaling networks. Based on efficacy results of the phase 2 study of patients (pts) with 131I-refractory differentiated thyroid cancer (RR-DTC), this phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT) was developed. Methods: This randomized, double-blind, placebo (PBO)-controlled study enrolled pts with RR-DTC with documented disease progression within 13 months (mo). Pts were stratified by age (≤65, >65 years), region and ≤1 prior VEGFR-targeted therapies and randomized 2:1 to LEN or PBO (24mg/d, 28-d cycle). Upon progression, pts receiving PBO could crossover to open-label LEN. The primary endpoint was PFS assessed by Independent Radiologic Review; secondary endpoints included overall response rate (ORR; complete response [CR] + PR), overall survival (OS) and safety. Results: 392 pts (63.0 years median age; 51.0% male) were randomized. Pts on LEN had a significantly prolonged PFS vs PBO (hazard ratio 0.21, 95% confidence interval [CI] 0.14–0.31; P <.0001); median PFS was LEN: 18.3 mo (95% CI 15.1–not evaluable), PBO: 3.6 mo (95% CI 2.2–3.7). A LEN PFS benefit was observed in all predefined subgroups; median LEN PFS for pts with prior vs no prior VEGF-therapy was 15.1 mo (n=66) and 18.7 mo (n=195), respectively. Rates (n) of CRs were LEN: 1.5% (4), PBO: 0; PRs were LEN: 63.2% (165), PBO: 1.5% (2).Median exposure duration was LEN: 13.8 mo, PBO: 3.9 mo; median time to LEN response was 2.0 mo. Median OS has not been reached; deaths per arm were LEN: 71 (27.2%), PBO: 47 (35.9%). The 5 most common LEN treatment-related adverse events (TRAEs; any grade) were hypertension (68%), diarrhea (59%), appetite decreased (50%), weight loss (46%), nausea (41%). LEN grade ≥3 TRAEs (≥5%) were hypertension (42%), proteinuria (10%), weight loss (10%), diarrhea (8%), appetite decreased (5%). The dose was reduced in 78.5% of pts and discontinued due to adverse events (AEs) in 14.2% of pts. Conclusions: LEN significantly improved PFS compared with PBO in pts with progressive RR-DTC. There were no unexpected toxicities and AEs were manageable. Clinical trial information: NCT01321554.

scholarly journals Changes in Weight and Substrate Oxidation in Overweight Adults Following Isomaltulose Intake During a 12-Week Weight Loss Intervention: A Randomized, Double-Blind, Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 2367 ◽  
Author(s):  
Lightowler ◽  
Schweitzer ◽  
Theis ◽  
Henry
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Energy Intake ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Body Weight Loss ◽  
Fat Oxidation ◽  
Obese Adults ◽  
Double Blind ◽  
Body Weight Reduction

Low-glycemic compared to high-glycemic diets have been shown to improve metabolic status and enhance fat oxidation. The randomized, double-blind, controlled intervention study aimed to evaluate the effects of an energy-reduced diet containing isomaltulose (ISO, Palatinose™) versus sucrose (SUC) on body weight loss. Sixty-four healthy overweight/obese adults were allocated to consume either 40g/d ISO or SUC added to an energy-reduced diet for 12 weeks. Anthropometric measurements, body composition, and energy metabolism were assessed at baseline and after 4, 8, and 12 weeks. Fifty participants (age: 40.7 ± 11.7 y; BMI: 29.4 ± 2.7 kg/m²) completed the study. During the 12 weeks, both groups significantly lost weight (p < 0.001), which was more pronounced following ISO (−3.2 ± 2.9 vs. −2.1 ± 2.6 kg; p = 0.258). Moreover, for participants in the ISO group, this was accompanied by a significant reduction in fat mass (ISO: −1.9 ± 2.5, p = 0.005; SUC: −0.9 ± 2.6%, p = 0.224). The overall decrease in energy intake was significantly higher in the ISO compared to that in the SUC group (p = 0.022). In addition, breakfast containing ISO induced a significantly lower increase in postprandial respiratory quotient (RQ) (mean incremental area under the curve (iAUC)2h for ISO vs. SUC: 4.8 ± 4.1 vs. 6.9 ± 3.1, p = 0.047). The results suggest that ISO in exchange for SUC may help to facilitate body weight reduction, lower postprandial RQ associated with higher fat oxidation, and reduce energy intake.

scholarly journals Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ralf Uebelhack ◽  
Udo Bongartz ◽  
Stephanie Seibt ◽  
Gordana Bothe ◽  
Pee Win Chong ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Placebo Group ◽  
Body Fat ◽  
Dose Group ◽  
Low Dose ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
High Dose ◽  
Double Blind

Objective. This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods. A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual’s energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results. After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p<0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p<0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported. Conclusions. These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.

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