All articles tagged with #randomized trial
A 54-participant, double-blind study found that a 13 g daily blend of dietary fibers from resistant dextrin, pectins, citrus fiber, and oat fiber improved spontaneous bowel movements and stool form versus placebo over 28 days in adults with functional constipation, with good tolerability; results suggest combined fibers may offer rapid relief, though larger, multicenter trials are needed.
A randomized, double-blind trial found that high-dose omega-3 algae supplements did not improve memory or cognition in adults at risk for dementia, even though blood and cerebrospinal fluid showed higher omega-3 levels. The researchers say benefits come from overall healthy lifestyle choices—exercise, sleep, and a Mediterranean-style diet with fatty fish—rather than supplements alone.
A small randomized trial in 15 adults with obstructive sleep apnea and sleep-maintenance difficulties found that taking 50 mg of quetiapine before bed increased total sleep time and reduced apnea events, but tripled morning attention lapses and worsened driving performance in a simulator. Researchers caution against driving for about 9.5 hours after dosing and note the study’s small size and single-night design, with sex-based differences in drug metabolism potentially influencing effects. Larger studies are needed to confirm the trade-offs between sleep benefits and daytime functioning.
An NIH-supported PATHWEIGH program implemented across 56 UCHealth primary care clinics and reaching about 274,000 patients reduced population weight gain by 0.58 kg over 18 months, increased weight-related care by 23%, and is being considered as a standard approach to obesity treatment in the U.S.
In the SYNCHRONIZE-MASLD phase 3 trial, 216 adults with obesity and metabolic dysfunction-associated steatotic liver disease received weekly survodutide 6.0 mg or placebo for 48 weeks. Survodutide met both co-primary endpoints, with 84.2% achieving ≥30% reduction in liver fat content (MRI-PDFF) versus 24.3% on placebo, and significant weight loss compared with placebo. About six in ten treated participants reached normalization of liver fat. The study used a dose-escalation period to 6.0 mg followed by a maintenance phase and included extensive safety monitoring. Secondary endpoints showed favorable changes in liver enzymes, liver stiffness/volume, insulin resistance, and other noninvasive liver tests. These results support survodutide as a potential therapy for obesity and MASLD, with data sharing and ongoing follow-up planned.
A small randomized trial at Karolinska Institutet tested a single 25 mg dose of psilocybin versus placebo, with structured psychological support, in 35 participants with recurrent depression not classified as treatment-resistant, and followed them for a year. By day eight, mood improvements appeared in the psilocybin group; by six weeks, more than half no longer met criteria for depression versus one in the placebo group, though self-rated benefits persisted for about three months. About one-third in each arm began antidepressants during follow-up, reflecting real-world care. Two participants in the psilocybin group experienced severe anxiety requiring medical attention. Limitations include small sample size and unblinding concerns, but the study broadens the potential target population for psychedelic-assisted therapy and underscores the need for larger trials and scalable regulatory frameworks for implementation.
In a small randomized trial of 35 participants with recurring depression, a single dose of psilocybin plus psychological support reduced depressive symptoms within days and provided benefits for just over three months versus placebo, where over half the psilocybin group no longer met depression criteria by six weeks, compared with limited improvement in the placebo group. After a year, the gap narrowed as placebo participants improved, highlighting the influence of expectations and the challenges of blinding. The study suggests psilocybin could help broader forms of depression but requires cautious interpretation and further research.
A four-week randomized trial in adults aged 65–75 tested four diets with different protein sources and fat–carbohydrate mixes. The omnivorous high-fat diet (OHF) had little impact on aging biomarkers, while three other diets—omnivorous high-carb (OHC) and two semi-vegetarian regimens (VHF, VHC)—reduced estimated biological age as measured by the Klemera-Doubal Method across 20 biomarkers (e.g., blood pressure, insulin, cholesterol, CRP). Findings are preliminary, with not all changes statistically significant, and longer-term studies are needed to determine durability and potential effects on age-related disease risk.
An experimental aldosterone synthase inhibitor, baxdrostat, lowered systolic BP by 8.1 mm Hg more than placebo and cut urine albumin by 55% after 26 weeks in 192 CKD patients with uncontrolled hypertension on standard therapy, hinting at kidney and cardiovascular protection; however, hyperkalemia was more common (41% vs 5%), and serious adverse events were higher (9% vs 3%). Baxdrostat is not FDA-approved, and Phase 3 trials (including BaxHTN and Bax24) are under way, with exploring combinations like baxdrostat plus dapagliflozin.
Ten-year follow-up of the FIDELITY randomized trial shows arthroscopic partial meniscectomy offers no functional or pain benefit versus sham for degenerative meniscal tears and may accelerate osteoarthritis progression; more patients in the surgical group required knee replacement or high tibial osteotomy. The findings, aligning with prior 1- and 5-year data, argue against using APM in this patient population except in specific acute or mechanical cases.
A new study argues that treating depression by boosting positive emotions—rather than just removing negative ones—may be more effective. Positive Affect Treatment (PAT) is a 15-session therapy designed to rebuild the brain’s capacity for joy, motivation, and reward through savoring, gratitude, and loving-kindness. In a randomized trial with 98 adults, PAT yielded greater overall clinical improvement and reduced suicidality and relapse risk compared with conventional therapies that target negative affect, with improvements linked to modulation of reward and threat processing.
A year-long randomized trial of 130 adults found that meeting 150 minutes per week of moderate-to-vigorous aerobic exercise significantly reduced long-term cortisol levels, suggesting regular exercise dampens the biology of stress and may support mental resilience and overall health; the study’s brain imaging also hinted at slower brain aging.
A year-long randomized trial found that adults who achieve 150 minutes per week of moderate-to-vigorous aerobic exercise experience a significant drop in long-term cortisol, indicating a lowered baseline stress level; in addition to reduced stress hormone, the exercise group showed slower brain aging and improved biological resilience against depression, anxiety, and heart disease, providing causal evidence that regular cardio benefits stress biology beyond immediate mood effects.
A large Lancet-published trial found that a behavioral hydration program—using Bluetooth water bottles, personalized fluid goals, financial incentives, reminders, and health coaching—increased fluid intake and urine output but did not reduce symptomatic kidney stone recurrence over two years. Enrolling 1,658 participants across six U.S. centers, the study highlights the challenge of maintaining very high hydration and suggests that prevention will require more personalized hydration targets, strategies to overcome real‑world barriers, and possibly additional therapies to keep minerals dissolved in urine.
In the VIVID randomized trial, Mass General Brigham researchers found that high-dose vitamin D3 did not reduce COVID-19 severity, hospitalizations, or transmission. However, among participants who consistently followed the supplementation regimen, there was a borderline-significant hint that long COVID symptoms eight weeks after infection were less common (21% vs 25% in the placebo group), meriting further study. The trial enrolled 1,747 COVID-positive adults and 277 household contacts across the U.S. and Mongolia, using a regimen of 9,600 IU/day for two days then 3,200 IU/day for four weeks, starting about three days after a positive test. The study, published in The Journal of Nutrition, emphasizes no clear acute benefits but suggests a potential long-COVID effect in adherent users.