scholarly journals SPECIFIC NATURAL BIOACTIVE TYPE 1 COLLAGEN PEPTIDES ORAL INTAKE REVERSE SKIN AGING SIGNS IN MATURE WOMEN

2016 ◽  
pp. 1-9
Author(s):  
L. Duteil ◽  
C. Queille-Roussel ◽  
Y. Maubert ◽  
J. Esdaile ◽  
C. Bruno-Bonnet ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Skin Aging ◽  
Skin Hydration ◽  
Type I ◽  
Double Blind ◽  
Crow’S Feet ◽  
Mature Women ◽  
Fish Collagen ◽  
Collagen Hydrolysates ◽  
Skin Biomechanics

Objective: To assess the anti-aging potential of three type I fish collagen hydrolysates (CH1=Naticol® BPMG, CH2=Naticol® HPMG, CH3=Naticol® 1000MG) on skin aging signs for three different body sites of mature women. Design: Double-blind, randomized and Placebo-controlled clinical study. Setting: Centre of Clinical Pharmacology Applied to Dermatology (CPCAD, Nice). Participants: Sixty women aged 46-69 years having skin aging signs on the face. Intervention: Participants were randomized to receive a once daily 5g dose of one of the CHs or Placebo for 8 weeks. Measurements: Skin biomechanics, skin hydration and visual assessment of the crow’s-feet wrinkles were evaluated after 4 and 8 weeks of treatment. Subject satisfaction questionnaire and Investigator global efficacy appreciation (IGEA) were also used. Results: Skin biomechanics indicated a significant improvement of skin firmness for the three CHs compared to Placebo, in particular for CH2. An increase of overall skin elasticity for CH3 (p = 0.017) and CH2 (p = 0.044) on the abdomen was also observed. This was corroborated by the significant decrease of the crow’s-feet wrinkle score at week 8 for both CH3 and CH2 (p=0.023 and p=0.014, respectively). Concerning the self-questionnaire, overall the number of positive responses was significantly higher for CH2 compared to Placebo and other CHs. For the IGEA, the number of favorable answers was greater for CH2 than for the Placebo group (80% vs. 36%, p= 0.025). A positive influence of CH treatments could be observed for skin hydration but failed to reach statistical significance. Conclusion: The tested type I fish collagen hydrolysates have beneficial effects on skin quality. In particular, CH2 demonstrated the greatest range of these effects including improvement of skin biomechanics, decrease of wrinkles, good subject satisfaction and no related adverse events.

scholarly journals The Effects of Skin Aging Associated with the Use of BioCell Collagen: A Randomized, Double-blind, Placebo-controlled Clinical Trial (P06-122-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Alexander Schauss ◽  
Stephen Schwartz ◽  
Kimberly Hammon ◽  
Anna Gafner Hardy ◽  
Norman Guttman ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Dietary Supplementation ◽  
Skin Surface ◽  
Skin Aging ◽  
Collagen Content ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Photographic Analysis ◽  
Crow’S Feet

Abstract Objectives The aim of the study intended to correlate the effects of the dietary supplement, BioCell Collagen, with any changes associated with skin aging, since dietary supplements claim cutaneous anti-aging properties for their products; however, research supporting these claims remains sparse. Methods A 12-week, randomized, double-blind, placebo-controlled trial of 128 female subjects, aged 39–59 (50.57 ± 5.55) randomly assigned to treatment or placebo. Intervention: Twice daily oral administration of a supplement containing 500 mg of a naturally occurring matrix of collagen type-II peptides, hyaluronic acid, and chondroitin sulfate, derived from chicken sternal cartilage, or placebo. Primary outcome measures: trans-epidermal water loss, viscoelasticity, hydration, collagen content, chromophore (melanin) content and hemoglobin level, and photographic analysis. Expert visual grading for facial lines/wrinkles, crow's feet lines/wrinkles, skin texture/smoothness, and skin tone. Secondary outcomes: Tolerance and incidence of adverse events. Presence of erythema and/or dryness determined tolerance. Participant's perception of the product's value. Results Dietary supplementation significantly reduced facial lines and wrinkles (p = 0.019), crow's feet lines/wrinkles (p = 0.05), increased skin elasticity (p = 0.05), cutaneous collagen content (p = 0.001), and improved indicators of youthful skin appearance and wrinkle width (p = 0.046), and decreased skin dryness and erythema, compared to placebo. There was no difference between supplement and placebo for skin surface water content or retention. Supplement was well tolerated with no reported adverse reactions. Conclusions Dietary supplementation of this chicken sternal cartilage extract supports the accumulation of types-I/III collagen in skin to promote increased elasticity and reduced skin wrinkling in women 39 to 59 years of age. Funding Sources BioCell Technology, LLC.

804 Tastes: Evidence on Preferences, Randomness, and Value from Double-Blind Wine Tastings

2012 ◽  
Vol 7 (2) ◽  
pp. 181-191 ◽  
Author(s):  
Jeffrey C. Bodington
Keyword(s):  
Statistical Significance ◽  
Mixture Distribution ◽  
Mixture Component ◽  
Type I ◽  
Double Blind ◽  
Position Bias ◽  
Ranking Procedures ◽  
The Mean ◽  
The Difference ◽  
Level Of Significance

AbstractResults for a total of 804 double-blind tastes by experienced tasters during nine tasting events are reported. T-test results reject the hypothesis that flight-position bias affects results. The distribution of ranks for a wine is a mixture distribution, and tests concerning the variance of that mixture distribution do not isolate the variance due to the randomness mixture component alone. T-statistics for the mean ranks of high- and low-ranking wines are over several standard deviations from a random expectation. T-tests show that the statistical significance of the difference between wine ranks is positively related to the difference in their mean ranks. At a 95% level of significance, the difference in ranks between the first- and second-place wines appears to be significant in 33% of tastings. At 95%, the difference in ranks between the first- and last-place wines appears to be significant in 100% of tastings. Monte Carlo simulation shows that much of those differences could be illusory and due to ranking procedures that lead to Type I errors. While the mean correlation coefficient between price per bottle and mean preference is a weakly positive 0.23, this may not indicate an inefficient market. (JEL Classifications: A10, C00, C12, D12)

scholarly journals Effect of Fish Collagen Hydrolysates on Type I Collagen mRNA Levels of Human Dermal Fibroblast Culture

Marine Drugs ◽  
2018 ◽  
Vol 16 (5) ◽  
pp. 144 ◽  
Author(s):  
Ana Sanchez ◽  
Maria Blanco ◽  
Begoña Correa ◽  
Ricardo I. Perez-Martin ◽  
Carmen Sotelo
Keyword(s):  
Type I Collagen ◽  
Dermal Fibroblast ◽  
Human Dermal Fibroblast ◽  
Fibroblast Culture ◽  
Type I ◽  
Mrna Levels ◽  
Collagen Mrna ◽  
Fish Collagen ◽  
Collagen Hydrolysates

Collagen formula with Djulis for improvement of skin hydration, brightness, texture, crow’s feet, and collagen content: A double‐blind, randomized, placebo‐controlled trial

2020 ◽  
Vol 20 (1) ◽  
pp. 188-194
Author(s):  
Ping Lin ◽  
Ruth Audy Alexander ◽  
Chia‐Hua Liang ◽  
Cheng Liu ◽  
Yung‐Hao Lin ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Collagen Content ◽  
Skin Hydration ◽  
Double Blind ◽  
Crow’S Feet

scholarly journals OR26-08 Efficacy and Safety of Higher Dulaglutide Doses (3.0 MG and 4.5 MG) When Added to Metformin in Patients With Type 2 Diabetes: A Phase 3, Randomized, Double-Blind, Parallel ARM Study (Award-11)

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Juan Pablo Frias ◽  
Luis Nevárez Ruiz ◽  
Ying Grace Li ◽  
Zhuoxin Yu ◽  
Zvonko Milicevic ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Glycemic Control ◽  
Adverse Events ◽  
Treatment Regimen ◽  
Safety Profile ◽  
Statistical Significance ◽  
Type I ◽  
Double Blind ◽  
Acceptable Safety Profile

Abstract Dulaglutide (DU) approved at doses of 0.75 and 1.5 mg once-weekly is an effective glucose lowering agent for treatment of type 2 diabetes (T2D). We hypothesized that higher investigational DU doses may provide further improvements in glucose control and body weight (BW) with an acceptable safety profile. The primary objective was to demonstrate superiority of once-weekly DU 3 mg and/or 4.5 mg to DU 1.5 mg for A1C change from baseline (BL) at 36 weeks (wks) in patients (pts) with inadequately controlled T2D on metformin therapy. Secondary objectives (controlled for multiplicity) included change in BW and % of pts achieving A1C <7% at 36 wks. Patients were randomized (1:1:1) to once-weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614). All pts initiated once-weekly DU 0.75 mg for 4 wks, followed by step-wise dose escalation every 4 wks to the randomized dose of 1.5 mg, 3 mg, or 4.5 mg. Two estimands were defined for efficacy analyses: an efficacy estimand (data on-treatment without rescue medication) and a treatment-regimen estimand (all data regardless of adherence or initiation of rescue). At BL, patients had a mean of: age 57.1 yrs, T2D duration 7.6 yrs, and A1C 8.6%, BW 95.7 kg, and BMI 34.2 kg/m2. Using the efficacy estimand, the DU 3 mg and 4.5 mg doses were superior to the DU 1.5 mg dose for A1C change from BL (1.5 mg, 1.53%; 3 mg, 1.71% [p=0.003]; 4.5 mg, 1.87% [p<0.001]), % of patients achieving HbA1c <7% (1.5 mg, 57%; 3.0 mg, 65% [p=0.006]; 4.5 mg, 71% [p<0.001]) and BW change from BL (1.5 mg, 3.1 kg; 3 mg, 4.0 kg [p=0.001]; 4.5 mg, 4.7 kg [p<0.001]). Using the treatment-regimen estimand, DU 4.5 mg was superior to DU 1.5 mg for A1C change, while the DU 3 mg dose did not achieve statistical significance (1.5 mg, 1.54%; 3.0 mg, 1.64% [p=0.096]; 4.5 mg, 1.77% [p<0.001]). Using the treatment-regimen estimand, more patients achieved A1C <7% with higher DU doses (1.5 mg, 50%; 3 mg, 56%; 4.5 mg, 62%) and results for BW change were similar to the efficacy estimand (1.5 mg, 3.0 kg; 3 mg, 3.8 kg; 4.5 mg, 4.6 kg), but the approach for type I error control did not permit formal statistical comparisons of these secondary objectives using this estimand. The safety profile for the higher DU doses was consistent with that known for 1.5 mg. The most commonly reported adverse events were nausea (DU 1.5 mg, 13.4%; DU 3 mg, 15.6%; DU 4.5 mg, 16.4%), vomiting (DU 1.5 mg, 5.6%; DU 3 mg, 8.3%; DU 4.5 mg, 9.3%), and diarrhea (DU 1.5 mg, 7.0%; DU 3 mg, 11.4%; DU 4.5 mg, 10.7%). Treatment discontinuation due to adverse events through 36 wks was low and similar across dose groups (DU 1.5 mg, 4.2%; DU 3 mg, 5.5%; DU 4.5 mg, 5.0%). In pts with T2D and inadequate glycemic control on metformin, escalation from DU 1.5 mg to DU 3 mg or DU 4.5 mg once-weekly provided clinically relevant, dose-related improvements in glycemic control and BW with an acceptable safety profile.

Double-blind controlled trial of azathioprine in children with newly diagnosed type I diabetes

Diabetes ◽  
1989 ◽  
Vol 38 (6) ◽  
pp. 779-783 ◽  
Author(s):  
J. J. Cook ◽  
I. Hudson ◽  
L. C. Harrison ◽  
B. Dean ◽  
P. G. Colman ◽  
...  
Keyword(s):  
Type I Diabetes ◽  
Controlled Trial ◽  
Type I ◽  
Newly Diagnosed ◽  
Double Blind

scholarly journals EXPRESS: Efficacy and Safety of Tadalafil in a Pediatric Population with Pulmonary Arterial Hypertension: Phase 3 randomized, Double Blind Placebo-Controlled Study

2021 ◽  
pp. 204589402110249
Author(s):  
David D Ivy ◽  
Damien Bonnet ◽  
Rolf MF Berger ◽  
Gisela Meyer ◽  
Simin Baygani ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Statistical Significance ◽  
Significance Testing ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Statistical Significance Testing ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Groups ◽  
Pulmonary Arterial

Objective: This study evaluated the efficacy and safety of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH). Methods: This phase-3, international, randomized, multicenter (24 weeks double-blind placebo controlled period; 2-year, open-labelled extension period), add-on (patient’s current endothelin receptor antagonist therapy) study included pediatric patients aged <18 years with PAH. Patients received tadalafil 20 mg or 40 mg based on their weight (Heavy-weight: ≥40 kg; Middle-weight: ≥25—<40 kg) or placebo orally QD for 24 weeks. Primary endpoint was change from baseline in 6-minute walk (6MW) distance in patients aged ≥6 years at Week 24. Sample size was amended from 134 to ≥34 patients, due to serious recruitment challenges. Therefore, statistical significance testing was not performed between treatment groups. Results: Patient demographics and baseline characteristics (N=35; tadalafil=17; placebo=18) were comparable between treatment groups; median age was 14.2 years (6.2 to 17.9 years) and majority (71.4%, n=25) of patients were in HW cohort. Least square mean (SE) changes from baseline in 6MW distance at Week 24 was numerically greater with tadalafil versus placebo (60.48 [20.41] vs 36.60 [20.78] meters; placebo-adjusted mean difference [SD] 23.88 [29.11]). Safety of tadalafil treatment was as expected without any new safety concerns. During study period 1, two patients (1 in each group) discontinued due to investigator’s reported clinical worsening, and no deaths were reported. Conclusions: The statistical significance testing was not performed between the treatment groups due to low sample size, however, the study results show positive trend in improvement in non invasive measurements, commonly utilized by clinicians to evaluate the disease status for children with PAH. Safety of tadalafil treatment was as expected without any new safety signals.

scholarly journals Linkage Disequilibrium in Domestic Sheep

Genetics ◽  
2002 ◽  
Vol 160 (3) ◽  
pp. 1113-1122
Author(s):  
A F McRae ◽  
J C McEwan ◽  
K G Dodds ◽  
T Wilson ◽  
A M Crawford ◽  
...  
Keyword(s):  
Linkage Disequilibrium ◽  
Type I Error ◽  
Statistical Significance ◽  
Domestic Sheep ◽  
Type I ◽  
Single Nucleotide ◽  
Microsatellite Genotype ◽  
Marker Distance ◽  
The Relationship ◽  
Two Populations

Abstract The last decade has seen a dramatic increase in the number of livestock QTL mapping studies. The next challenge awaiting livestock geneticists is to determine the actual genes responsible for variation of economically important traits. With the advent of high density single nucleotide polymorphism (SNP) maps, it may be possible to fine map genes by exploiting linkage disequilibrium between genes of interest and adjacent markers. However, the extent of linkage disequilibrium (LD) is generally unknown for livestock populations. In this article microsatellite genotype data are used to assess the extent of LD in two populations of domestic sheep. High levels of LD were found to extend for tens of centimorgans and declined as a function of marker distance. However, LD was also frequently observed between unlinked markers. The prospects for LD mapping in livestock appear encouraging provided that type I error can be minimized. Properties of the multiallelic LD coefficient D′ were also explored. D′ was found to be significantly related to marker heterozygosity, although the relationship did not appear to unduly influence the overall conclusions. Of potentially greater concern was the observation that D′ may be skewed when rare alleles are present. It is recommended that the statistical significance of LD is used in conjunction with coefficients such as D′ to determine the true extent of LD.

scholarly journals Phase 1 double-blind randomized safety trial of the Janus kinase inhibitor tofacitinib in systemic lupus erythematosus

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Sarfaraz A. Hasni ◽  
Sarthak Gupta ◽  
Michael Davis ◽  
Elaine Poncio ◽  
Yenealem Temesgen-Oyelakin ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Kinase Inhibitor ◽  
Janus Kinase ◽  
Controlled Clinical Trial ◽  
Type I ◽  
Systemic Lupus ◽  
Double Blind ◽  
Premature Cardiovascular Disease ◽  
Increased Risk

AbstractIncreased risk of premature cardiovascular disease (CVD) is well recognized in systemic lupus erythematosus (SLE). Aberrant type I-Interferon (IFN)-neutrophil interactions contribute to this enhanced CVD risk. In lupus animal models, the Janus kinase (JAK) inhibitor tofacitinib improves clinical features, immune dysregulation and vascular dysfunction. We conducted a randomized, double-blind, placebo-controlled clinical trial of tofacitinib in SLE subjects (ClinicalTrials.gov NCT02535689). In this study, 30 subjects are randomized to tofacitinib (5 mg twice daily) or placebo in 2:1 block. The primary outcome of this study is safety and tolerability of tofacitinib. The secondary outcomes include clinical response and mechanistic studies. The tofacitinib is found to be safe in SLE meeting study’s primary endpoint. We also show that tofacitinib improves cardiometabolic and immunologic parameters associated with the premature atherosclerosis in SLE. Tofacitinib improves high-density lipoprotein cholesterol levels (p = 0.0006, CI 95%: 4.12, 13.32) and particle number (p = 0.0008, CI 95%: 1.58, 5.33); lecithin: cholesterol acyltransferase concentration (p = 0.024, CI 95%: 1.1, −26.5), cholesterol efflux capacity (p = 0.08, CI 95%: −0.01, 0.24), improvements in arterial stiffness and endothelium-dependent vasorelaxation and decrease in type I IFN gene signature, low-density granulocytes and circulating NETs. Some of these improvements are more robust in subjects with STAT4 risk allele.

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