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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.

ABSTRACT: 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.

SUBMITTER: Uebelhack R

PROVIDER: S-EPMC6377993 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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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.

Uebelhack Ralf R Bongartz Udo U Seibt Stephanie S Bothe Gordana G Chong Pee Win PW De Costa Patricia P Wszelaki Natalia N

Journal of obesity 20190203

<h4>Objective</h4>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.<h4>Methods</h4>A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m<sup>2</sup>) 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 i ...[more]

PMID: 30863632

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Project description:The effect of the novel IQP-AE-103 (proprietary combination of dehydrated okra powder and inulin) on body weight reduction and the association with changes in microbiota composition were investigated in a double-blind, randomized, placebo-controlled trial. A total of seventy-two overweight or moderately obese subjects with a body mass index of ≥25 and <35 kg/m2 were randomly allocated to receive IQP-AE-103 or placebo; each group received two IQP-AE-103 or placebo capsules three times daily, respectively. Body weight, body fat, waist circumference, and hip circumference were measured, and fecal samples were collected at baseline and after 12 weeks of intervention. Using 16S rRNA gene sequencing on the fecal samples, the microbiota dissimilarity, diversity, and differences in relative abundance between or within groups were analyzed. At the end of the study, body weight was significantly reduced in the IQP-AE-103 group compared with the placebo group, 5.16 ± 2.39 kg vs. 0.97 ± 2.09 kg (p < 0.001). Subjects from the IQP-AE-103 group who achieved a reduction of ≥5% of total body weight from baseline (hereafter referred to as 5% responders or IQP5) had a mean body weight reduction of 6.74 ± 1.94 kg, significantly greater than the placebo group (p < 0.001). Using Lefse and statistical analysis, subjects in the IQP-AE-103 group had a significantly lower relative abundance of Firmicutes than the placebo group (p < 0.05) after 12 weeks of intervention. The 5% responders from the IQP-AE-103 group had a remarkable 4.6-fold higher relative abundance of Akkermansia muciniphila than the placebo group (p < 0.05). As the significant differences between groups were only observed post-intervention, the overall differences in microbiota profile suggest that the weight loss in overweight and moderately obese subjects who consumed IQP-AE-103 for 12 weeks is accompanied by a positive change in microbiota composition. These changes might be linked to the beneficial effects of microbiome modulations in alleviating obesity and metabolic syndrome. To the best of our knowledge, we are the first to report over-the-counter (OTC) supplementation that results in both significant changes in weight and favorable shifts on the subject microbiota profile. The trial is registered under ClinicalTrials.gov Identifier no. NCT03058367.

Project description:IntroductionThe aim of this study was to evaluate the benefit and tolerability of two dosages of a proprietary flaxseed mucilage (IQP-LU-104) in reducing body weight in overweight and moderately obese individuals.MethodsIn a double-blind, randomized, placebo-controlled, bi-center trial, 108 participants (body mass index [BMI] 25-<35 kg/m2) were randomly allocated to receive either IQP-LU-104 high dose (104HD), IQP-LU-104 low dose (104LD), or placebo. Participants were instructed to consume 1 sachet of the investigational product (containing IQP-LU-104 or matching placebo) before or with main meals twice daily and to follow a balanced but hypocaloric diet (20% reduction of individual's daily energy requirements) for 12 weeks. At week 0 (baseline), and weeks 4, 8, and 12 of the intervention periods, the participants' body weight, BMI, body fat composition, and waist and hip circumferences were measured. Blood samples were collected for safety assessment at screening visit (week -2) and at the end of the study. Adverse events were assessed by the investigators through interviewing the participants and were recorded at every visit post screening.ResultsAt the end of the 12-week study, body weight reduction was greater in the 104HD group (4.96 ± 1.89 kg, p < 0.001 vs. placebo) and 104LD group (3.70 ± 2.57 kg, p < 0.001 vs. placebo) compared to the placebo group (1.33 ± 2.05 kg). 68% and 46% of participants in the 104HD group (p < 0.001 vs. placebo) and 104LD group (p = 0.002 vs. placebo), respectively, experienced at least 5% weight loss, compared to 9% of participants in the placebo group. Significant decreases in waist and hip circumferences were observed in both the 104HD and 104LD groups compared to the placebo group (each p < 0.001). 104HD group had significantly higher reduction in body fat mass (4.25 ± 5.86 kg) than the placebo group (1.06 ± 3.20 kg) (p = 0.002). Respiratory tract infections and gastrointestinal symptoms were the main adverse events reported and none of the adverse events were related to the intake of IQP-LU-104.ConclusionResults demonstrated IQP-LU-104 is safe and efficacious in body weight reduction at both dosages in overweight and moderately obese individuals.

Project description:BackgroundKrill powder is rich in bioactive ingredients such as eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), phospholipids, protein and astaxanthin. Containing dominantly EPA, it is considered to be effective in lowering lipids, foremost serum triglycerides and LDL cholesterol. Krill-derived protein hydrolysates/peptides may have positive effect on blood pressure and astaxanthin has anti-oxidative and anti-inflammatory properties. Thus, krill powder has a lot of potential in improving lipid and metabolic profile and reinforcing the activity of the antioxidant system. However, randomized clinical trials on krill powder are scarce and systematic data of krill meal on human safety is limited. Some of the earlier studies have reported several, non-serious adverse events, mostly related to gastrointestinal tract, but systematic sufficiently powered study on safety is lacking. The aim of this study was to collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.MethodsThe study was a randomised, double-blinded, placebo-controlled intervention study with 35 overweight subjects with mildly or moderately elevated blood pressure, who took 4 g krill oil powder or 4 g of placebo during an 8-week follow-up period. The study consisted of a pre-screening, screening, day 0 baseline (randomization visit) and three follow-up visits on days 14, 28 and 56. The reported adverse events in the groups were compared as primary endpoint and haematological safety parameters and changes in systolic and diastolic pressure and blood total and lipoprotein lipids were measured as secondary end points.ResultsThere were in total 80 reported adverse events during the follow-up; 50 in placebo and 30 in krill powder group. Gastrointestinal symptoms (flatulence, heartburn and diarrhea) were the most commonly reported among those probably related to the test products. No serious adverse events were reported. The mean value of all measured hematology variables remained within the reference values in all study subject and no significant changes were observed in blood pressure or lipid values.ConclusionsThe results seem to indicate that using krill powder as a source for EPA and DHA is safe in therapeutic dose and the risk of adverse events, let alone serious ones, is low.Trial registrationClinicalTrials.gov, NCT03112083 , retrospectively registered.

Project description:BackgroundFinding some convenient and economical indicators to initially screen overweight and obese patients at high risk of kidney stone recurrence can help them prevent stone recurrence with lower medical cost. The purpose of this article is to determine the clinical value of Ae index (Apo B × 1000/eGFR) as an independent predictor for kidney stone recurrence in overweight and obese populations.MethodsWe queried the electronic medical records of patients with kidney stone operated at our hospital from March 2016 to March 2022, and selected BMI ≥ 25 kg/m2 as the study population and divided the patients into stone recurrence group and non-recurrence group. Relevant parameters of routine blood and biochemical test, glycated serum protein (GSP), and history of hypertension and hyperglycemia were collected. Then the Chi-square test, independent samples t-test or Wilcoxon rank-sum test were used to calculate the differences between the two groups of data. Next, we performed univariate and multivariate logistic regression analysis to screen out the most significant variables Apo B and eGFR, and then we calculated the Ae index using the formula Apo B × 1000/eGFR, and analyzed the relationship between Ae index and kidney stone recurrence.ResultsUnivariate analysis found that Apo B (OR:8.376,95%CI:3.093-22.680), Creatinine (OR:1.012,95%CI:1.003-1.021), Cystatin C(OR:2.747,95%CI:1.369-5.508), LDL-C (OR:1.588,95%CI:1.182-2.134), TC (OR:1.543,95%CI:1.198-1.988) were positively associated, eGFR (OR:0.980,95%CI:0.970-0.991) was negatively associated with kidney stone recurrence. And multivariate logistic regression analysis suggested that Apo B (OR:11.028, 95%CI:3.917-31.047) and eGFR (OR:0.976, 95%CI:0.965-0.988) were the most significant factors. Then we calculated Ae index and analyzed it, the sensitivity was 74.26% and the specificity was 60.00%, higher than either individual variable. Its smoothed curve revealed a non-linear relationship between them with the inflection point of 9.16. And the OR on the left side of the inflection point was 1.574 (95% CI: 1.228-2.018), whereas the OR on the right side of the inflection point was 1.088 (95% CI: 1.007-1.177).ConclusionsAe index is an easily calculated and obtained index that has some predictive value for kidney stone recurrence in overweight and obese patients, which is of interest.

Project description:BackgroundThe risk of symptomatic intracranial haemorrhage (sICH) after thrombolysis is low but severe. Lower dose of alteplase may reduce the risk of sICH. We aim to identify subsets of patients who could beneﬁt from lower dose of alteplase compared with standard dose.MethodsData from two observational registries were pooled together. A total of 3479 patients who had acute ischaemic stroke were entered into the interaction tree model. The response variable was the rate of sICH per the definition of the National Institute of Neurological Disorders and Stroke Study. Clinical improvement was measured by the National Institutes of Health Stroke Scale (NIHSS) and defined as NIHSS 0 or 1 or an improvement of more than 4 points (within 7 days or at discharge). Rare event logistic regression was performed to analyse the OR of safety outcome.ResultsTo optimise the interaction effect between tissue plasminogen activator (tPA) dosage (standard/lower) and patient subgroups, three subgroups based on the severity of stroke were identified: (1) NIHSS ≤4, (2) NIHSS between 5 and 14, and (3) NIHSS ≥15. The estimated difference of OR of having sICH was 2.71 (95% CI 0.80 to 7.69, p=0.10) for mild, 0.13 (95% CI 0.02 to 0.68, p=0.01) for moderate, and 0.65 (95% CI 0.19 to 2.55, p=0.52) for severe, respectively. In addition, patients who had moderate stroke treated with lower dose had comparable efficacy outcome (OR 1.23, 95% CI 0.71 to 2.13, p=0.45).ConclusionOur analysis demonstrated that in patients who had moderate stroke, lower doses of alteplase are associated with significant sICH reduction and non-inferior performance in efficacy, compared with those in the standard dose group.Trial registration numberThe TIMS-China was a national prospective stroke registry on thrombolytic therapy using intravenous tPA in patients who had acute ischaemic stroke. The results were initially published in 2012 without a clinical trial registration number. The Shanghai Stroke Service System was registered at www.clinicaltrial.gov (NCT02735226).

Project description:BackgroundMany adiposity traits have been related to health complications and premature death. These adiposity traits are intercorrelated but their underlying structure has not been extensively investigated. We report on the degree of commonality and specificity among multiple adiposity traits in normal-weight and moderately overweight adult males and females (mean body mass index (BMI)=22.9 kg m(-2), s.d.=2.4).MethodsA total of 75 healthy participants were assessed for a panel of adiposity traits including leg, arm, trunk, total fat masses and visceral adipose tissue (VAT) derived from dual energy X-ray absorptiometry (DXA), hepatic and muscle lipids from proton magnetic resonance spectroscopy, fat cell volume from an abdominal subcutaneous adipose tissue biopsy (n=36) and conventional anthropometry (BMI and waist girth). Spearman's correlations were calculated and were subjected to factor analysis.ResultsArm, leg, trunk and total fat masses correlated positively (r=0.78-0.95) with each other. VAT correlated weakly with fat mass indicators (r=0.24-0.31). Intrahepatic lipids (IHL) correlated weakly with all fat mass traits (r=0.09-0.34), whereas correlations between DXA depots and intramyocellular lipids (IMCL) were inconsequential. The four DXA fat mass measures, VAT, IHL and IMCL depots segregated as four independent factors that accounted for 96% of the overall adiposity variance. BMI and waist girth were moderately correlated with the arm, leg, trunk and total fat and weakly with VAT, IHL and IMCL.ConclusionAdiposity traits share a substantial degree of commonality, but there is considerable specificity across the adiposity variance space. For instance, VAT, IHL and IMCL are typically poorly correlated with each other and are poorly to weakly associated with the other adiposity traits. The same is true for BMI and waist girth, commonly used anthropometric indicators of adiposity. These results do not support the view that it will be possible to identify adequate anthropometric indicators of visceral, hepatic and muscle lipid content in normal-weight and moderately overweight individuals.

Project description:OBJECTIVES:We examined the effect of a telemedical coaching (TMC) programme accompanied with or without telemonitoring on weight loss in an occupational healthcare setting with a three-armed randomised controlled trial (NCT01837134 'Pre-results'). METHODS:Overweight employees (n=104, body mass index [BMI] ?25?kg/m2) were invited by their medical corporate department and randomised into either a TMC group (n=34) or in one of the two control groups (C1, n=34; C2, n=36). TMC and C1 were equipped with telemonitoring devices (scales and pedometers) at baseline, and C2 after 6 months. Telemonitoring devices automatically transferred data into a personalised online portal. TMC was coached with weekly care calls in months 3-6 and monthly calls from months 7 to 12. C2 had a short coaching phase in months 6-9. C1 received no further support. After the 12-month intervention phase, participants could take advantage of further company health promotion offers. Follow-up data were determined after 12 months of intervention and per-protocol (PP) and intention-to-treat (ITT) analyses were performed. Weight change was followed up after 36 months. Estimated treatment difference (ETD) was calculated for weight reduction. RESULTS:ETD from TMC to C1 (-3.6?kg 95% CI -7.40 to -0.1, p=0.047) and to C2 (-4.2?kg [-7.90 to -0.5], p=0.026) was significantly different at the 12?months follow-up in the PP-analysis, but lost significance in the ITT analysis. All groups reduced weight after 12 months (-3.3 to -8.4?kg [5.5-10.3?kg], all p<0.01) and sustained it during the 36?months follow-up (-4.8 to -7.8?kg [5.6-12.8?kg], all p<0.01). ETD analyses revealed no difference between all groups neither in the PP nor in the ITT analysis at the 3?years follow-up. All groups reduced BMI, systolic and diastolic blood pressure and improved eating behaviour in the PP or ITT analyses. CONCLUSIONS:TMC and/or telemonitoring support long-term weight reduction in overweight employees. The combination of both interventions points towards an additional effect. TRIAL REGISTRATION NUMBER:NCT01837134.

Dataset Information

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.

Publications

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.

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