Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial)

IntroductionInfertility is a worldwide problem and about 10%–15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples, a male factor is involved. Most of the male infertile cases are characterised as ‘idiopathic’, except for a small percentage of cases which are causative by a genetic aetiology. In the past decade, the role of oxidative stress related to sperm quality has been researched thoroughly and estimated to be the problem in 25%–87% of male infertility cases. Impryl is a nutritional supplement which works on the metabolic system and the regulation of oxidative stress by activating the 1-carbon cycle and therefore recycling of homocysteine. We hypothesise that the nutritional supplement Impryl in men of infertile couples might improve the ongoing pregnancy rate.Methods and analysisWe designed a multicentre, randomised, double-blind, placebo-controlled clinical trial. We aimed to include 1200 male adults aged 18–50 years, part of a couple that is diagnosed with infertility. The couple will either start or has already been started with fertility treatment, that is, expectative management (duration of 6 months), intrauterine insemination (IUI) with or without mild ovarian stimulation or ovulation induction, either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment. Male participants will be randomised in either the Impryl or the placebo group, with identical appearance of the tablets to be distributed (doses: one tablet each day), for a total duration of maximal 6 months. Patients can start directly with fertility treatment and/or natural conception. The primary outcome is the number of ongoing pregnancies confirmed by ultrasound at ≥10 to 12 weeks, and conceived in the time window between randomisation up to and including month 6 of intervention use. Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count. Furthermore the number of pregnancies conceived in the optimal intervention time window (after full spermatogenesis of 72 days), overall number of pregnancies, time to pregnancy, embryo fertilisation rate in IVF/ICSI, embryo-utilisation rate in IVF/ICSI, number of miscarriages, live birth rate and adverse events are documented within the study period of 15 months.Ethics and disseminationThe protocol is approved by the local medical ethical review committee at the Radboud University Medical Centre and by the national Central Committee on Research Involving Human Subjects. Findings will be shared with the academic and medical community, funding and patient organisations in order to contribute to optimisation of medical care and quality of life for patients with infertility.Trial registration numbersNCT03337360 and NTR6551.

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Effects of a Single Oral Megadose of Vitamin D3 on Inflammation and Oxidative Stress Markers in Overweight and Obese Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Diabetes Metabolic Syndrome and Obesity Targets and Therapy ◽

10.2147/dmso.s285597 ◽

2021 ◽

Vol Volume 14 ◽

pp. 525-534

Author(s):

Laine de Carvalho Guerra Pessoa Mamede ◽

Rafaela Lira Formiga Cavalcanti de Lima ◽

Alexandre Sérgio Silva ◽

João Carlos Lima Rodrigues Pita ◽

Nadjeanny Ingrid Galdino Gomes ◽

...

Keyword(s):

Oxidative Stress ◽

Clinical Trial ◽

Vitamin D3 ◽

Controlled Clinical Trial ◽

Oxidative Stress Markers ◽

Obese Women ◽

Double Blind ◽

Double Blind Placebo ◽

Stress Markers ◽

And Oxidative Stress

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The effects of resveratrol on markers of oxidative stress in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial

Acta Diabetologica ◽

10.1007/s00592-017-1098-3 ◽

2018 ◽

Vol 55 (4) ◽

pp. 341-353 ◽

Cited By ~ 44

Author(s):

ShadiSadat Seyyedebrahimi ◽

Hadi Khodabandehloo ◽

Ensieh Nasli Esfahani ◽

Reza Meshkani

Keyword(s):

Oxidative Stress ◽

Type 2 Diabetes ◽

Clinical Trial ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Markers Of Oxidative Stress

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Evaluation of the Effects ofVaccinium arctostaphylosL. Fruit Extract on Serum Lipids and hs-CRP Levels and Oxidative Stress in Adult Patients with Hyperlipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/217451 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 21

Author(s):

Rasool Soltani ◽

Mustafa Hakimi ◽

Sedigheh Asgary ◽

Syed Mustafa Ghanadian ◽

Mahtab Keshvari ◽

...

Keyword(s):

Oxidative Stress ◽

Clinical Trial ◽

Serum Levels ◽

Adult Patients ◽

Controlled Clinical Trial ◽

Fruit Extract ◽

Double Blind ◽

Double Blind Placebo ◽

Hs Crp ◽

And Oxidative Stress

Background.Dyslipidemia produces atherosclerosis, which in turn results in coronary artery disease (CAD). Atherosclerosis is being considered as an inflammatory disease.Vaccinium arctostaphylosL. is a plant with fruits rich in anthocyanins. The aim of this study was to evaluate the effects of fruit extract of this plant on serum levels of lipids, hs-CRP, and malondialdehyde (MDA) as a marker of oxidative stress, in hyperlipidemic adult patients.Methods.In this randomized, double-blind, placebo-controlled clinical trial, 50 hyperlipidemic adult patients were randomly and equally assigned to receive either medicinal (V. arctostaphylosfruit extract) or placebo capsules twice daily for 4 weeks. Each medicinal capsule contained 45 ± 2 mg of anthocyanins. Fasting serum levels of total cholesterol, TG, LDL-C, HDL-C, hs-CRP, and MDA were obtained before and after the intervention and compared.Results. V. arctostaphylosfruit extract significantly reduced total cholesterol (P<0.001), LDL-C (P=0.004), TG (P<0.001), and MDA (P=0.013) compared to placebo but did not have any significant effect on HDL-C (P=0.631) and hs-CRP (P=0.190).Conclusion.Fruit extract ofVaccinium arctostaphyloshas beneficial effects on serum lipid profile and oxidative stress in hyperlipidemic adult patients. Therefore, it could be considered as a supplement for treatment of dyslipidemia and prevention of atherosclerosis development.

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Evaluation of a nutritional supplement for the alleviation of pain associated with feline degenerative joint disease: a prospective, randomized, stratified, double-blind, placebo-controlled clinical trial

Journal of Feline Medicine and Surgery ◽

10.1177/1098612x211053484 ◽

2021 ◽

pp. 1098612X2110534

Author(s):

Rachael Cunningham ◽

Margaret E Gruen ◽

Andrea Thomson ◽

B Duncan X Lascelles

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Chondroitin Sulfate ◽

Outcome Measures ◽

Nutritional Supplement ◽

Degenerative Joint Disease ◽

Joint Disease ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo

Objectives The purpose of this study was to evaluate the pain-alleviating and activity-enhancing effects of glucosamine/chondroitin sulfate (Dasuquin) in cats that had degenerative joint disease (DJD) and owner-noted mobility/activity impairment. We hypothesized that the nutritional supplement would produce pain-relieving and activity-enhancing effects in cats with painful DJD. Methods In this prospective, randomized, stratified, double-blind, placebo-controlled clinical trial, 59 cats with DJD pain were assigned to receive a placebo (n = 30) or supplement (n = 29) for 6 weeks after 2 weeks of placebo. Outcome measures (at-home accelerometry and client-specific outcome measures [feline (CSOMf); Feline Musculoskeletal Pain Index (FMPI); quality of life (QoL)]; and veterinarian examination) were collected at days 14, 28, 42 and 56. Results Twenty-seven cats in the treatment group and 30 in the placebo group completed the trial. Within the first 2 weeks (placebo administration to all cats), 78% of all cats had an improvement in CSOMf scores. Both groups showed significant improvement at most time points in CSOMf, FMPI, QoL and pain scores, with the placebo group showing greater improvement than the supplement group (significant for CSOMf [ P = 0.01]). Overall, no differences in activity were seen between the groups. Cumulative distribution function analysis indicated that for most levels of activity, the placebo-treated cats were more active; however, the least active cats were more active on the supplement ( P = 0.013). Conclusions and relevance This study showed a strong placebo effect. The glucosamine/chondroitin sulfate supplement did not show pain-relieving effects when compared with placebo.

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