scholarly journals Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Barbara Grube ◽  
Pee-Win Chong ◽  
Felix Alt ◽  
Ralf Uebelhack
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Controlled Trial ◽  
Weight Maintenance ◽  
Body Weight Loss ◽  
Controlled Study ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Initial Weight Loss

Background.Litramine (IQP-G-002AS) was shown to be effective and safe for weight loss in overweight and obese subjects. However, long-term effectiveness on maintenance of body weight loss has yet to be ascertained.Objective.To assess effect of Litramine on maintenance of body weight loss.Methods.A double-blind, randomised, placebo-controlled trial on overweight and obese patients was conducted over two sites in Germany for 24 weeks. Subjects with documented previous weight loss of 3% over the last 3–6 months were randomised to groups given either Litramine (3 g/day) or a matching placebo. Primary endpoints were difference of mean body weight (kg) between baseline and end of study and maintenance of initially lost body weight in verum group, where maintenance is defined as ≤1% weight gain.Results.Subjects who were taking Litramine lost significantly more body weight compared to the subjects taking placebo who gained weight instead (-0.62±1.55 kg versus1.62±1.48 kg,p<0.001). More importantly, 92% of subjects in Litramine group were able to maintain their body weight after initial weight loss, versus 25% in placebo group. No serious adverse events were reported throughout.Conclusion.Litramine is effective and safe for long-term body weight maintenance.Trial Registration.This trial is registered with Clinicaltrials.gov identifier:NCT01505387.

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 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 MON-LB101 5-Year Data of an Aggressive Pharmacological Approach to Moderate and Morbid Obesity: Is Prevention of Bariatric Surgery Feasible in the Long Run?

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Flavio Cadegiani
Keyword(s):  
Bariatric Surgery ◽  
Morbid Obesity ◽  
Weight Loss ◽  
Body Weight ◽  
Weight Regain ◽  
Morbidly Obese ◽  
Biochemical Profile ◽  
Initial Weight ◽  
Initial Weight Loss

Abstract Background: Maintenance of weight loss in patients that undergo weight loss interventions is highly challenging, irrespective of the type of approach to obesity (whether surgical, pharmacological, or non-pharmacological). We proposed a protocol of an aggressive clinical treatment for obesity aiming to prevent the need of bariatric surgery, in patients unwilling to undergo this procedure, by proposing a protocol that included the combination of different anti-obesity medications and non-pharmacological modalities, for longer duration, and with an active approach to prevent weight regain. Our initial 2-year data showed that 93% (40 of 43 patients) with moderate and morbid obesity were able to avoid the need of bariatric surgery, with concomitant improvements of the biochemical profile. However, whether these patients would maintain their successful rates after five years was uncertain. Our objective is to describe the efficacy and safety of a long term (5-year data) pharmacological and multi-modal treatment for moderate and severe obesity. Methods: The 40 patients that were successful in the two-year approach in our obesity center (Corpometria Institute, Brasilia, DF, Brazil) were enrolled. A long-term anti-obesity protocol was employed, with continuous or intermittent use of anti-obesity drugs, trimestral body composition analysis, psychotherapy, visit to a nutritionist every four months, and both resistance and endurance exercises at least four times a week. Body weight (BW), total weight excess (TWE), body fat, markers of lipid and glucose metabolism, liver function, and inflammation were analyzed. Subjects that dropped out were considered as weight regain. Therapeutic success for the 5-year follow-up included as the maintenance of &gt;20% loss of the initial BW loss, and no weight regain (or &lt; 20% of the initial weight loss). Results: A total of 27 patients (67.5%) were able to maintain the body weight, seven dropped out, and six regained more than 20% of the initial weight loss. Of these, 21 (77.8%) had significant further increase of muscle mass and decrease of fat loss, while 17 (63.0%) had further weight loss (p &lt; 0.05), compared to the 2-year data. Improvements on the biochemical profile persisted in all 27 patients, and had significant further improvements in 24 (88.9%) of these patients. Conclusion: The risk of weight regain five years after a weight loss treatment for obesity was significantly lower compared to previous literature, and comparable to the long-term outcomes of bariatric procedures. An aggressive, structured, and long-term clinical weight loss approach has been shown to be feasible, even for morbidly obese patients.

scholarly journals Dietary supplementation with n-3 PUFA does not promote weight loss when combined with a very-low-energy diet

2012 ◽  
Vol 108 (8) ◽  
pp. 1466-1474 ◽  
Author(s):  
Irene A. Munro ◽  
Manohar L. Garg
Keyword(s):  
Weight Loss ◽  
Controlled Trial ◽  
Weight Maintenance ◽  
Maintenance Phase ◽  
Fold Increase ◽  
Low Energy ◽  
Double Blind ◽  
Very Low Energy Diet ◽  
Randomised Controlled ◽  
Low Energy Diet

Obesity is associated with elevated levels of inflammation and metabolic abnormalities which are linked to CVD. The aim of the present study was to investigate whether long-chain n-3 PUFA (LCn-3PUFA), combined with a very-low-energy diet (VLED), facilitated weight loss and weight maintenance, and improvements in blood lipids and inflammatory mediators. This was a double-blind, randomised, controlled trial with two parallel groups. For 14 weeks, one group consumed 6 × 1 g capsules/d of monounsaturated oil (placebo group, PB), and the other group consumed 6 × 1 g capsules/d of LCn-3PUFA (fish oil group, FO), each comprising 70 mg EPA and 270 mg DHA. Both groups were on VLED for 4 weeks (n 14 PB, n 18 FO), which was then followed by 10 weeks of weight maintenance (n 12 PB, n 17 FO). Fasting blood samples, anthropometric measurements and 3 d food diaries were collected at baseline, at 4 and 14 weeks. A greater-than-2-fold increase occurred in plasma levels of EPA and DHA in the FO group (P < 0·001). At 4 weeks, the mean weight loss was − 6·54 (sd 2·08) kg ( − 6·9 %) for PB and − 6·87 (sd 1·83) kg ( − 7·7 %) for FO. At week 14, after the maintenance phase, there was a further mean decrease in weight, − 1·57 (sd 3·7) kg (1·85 %) for PB and − 1·69 (sd 2·32) kg ( − 1·9 %) for FO. Both groups experienced improved metabolic profiles and there was a significant reduction in fat mass for the FO group at week 14 but not for PB. However, it would appear that supplementation with LCn-3PUFA had no significant effect on weight loss or weight maintenance over the 14 weeks.

scholarly journals Effects of green tea on weight maintenance after body-weight loss

2004 ◽  
Vol 91 (3) ◽  
pp. 431-437 ◽  
Author(s):  
Eva M. R. Kovacs ◽  
Manuela P. G. M. Lejeune ◽  
Ilse Nijs ◽  
Margriet S. Westerterp-Plantenga
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Green Tea ◽  
Weight Regain ◽  
Weight Maintenance ◽  
Epigallocatechin Gallate ◽  
Body Weight Loss ◽  
Caffeine Consumption ◽  
Very Low Energy Diet ◽  
Obese Subjects

The present study was conducted to investigate whether green tea may improve weight maintenance by preventing or limiting weight regain after weight loss of 5 to 10% in overweight and moderately obese subjects. The study had a randomised, parallel, placebo-controlled design. A total of 104 overweight and moderately obese male and female subjects (age 18–60 years; BMI 25–35kg/m2) participated. The study consisted of a very-low-energy diet intervention (VLED; 2·1MJ/d) of 4 weeks followed by a weight-maintenance period of 13 weeks in which the subjects received green tea or placebo. The green tea contained caffeine (104mg/d) and catechins (573mg/d, of which 323mg was epigallocatechin gallate). Subjects lost 6·4 (sd 1·9) kg or 7·5 (sd 2·2) % of their original body weight during the VLED (P<0·001). Body-weight regain was not significantly different between the green tea and the placebo group (30·5 (sd 61·8) % and 19·7 (sd 56·9)%, respectively). In the green tea treatment, habitual high caffeine consumption was associated with a higher weight regain compared with habitual low caffeine consumption (39 (sd 17) and 16 (sd 11)%, respectively; P<0·05). We conclude that weight maintenance after 7·5% body-weight loss was not affected by green tea treatment and that habitual caffeine consumption affected weight maintenance in the green tea treatment.

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 &lt; 0.05). Total cholesterol, LDL, and oxidized LDL decreased to a greater extent following HPF at D 84 (P &lt; 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 &lt; 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.

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.

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