All articles tagged with #randomized trial
A small randomized crossover trial in healthy middle-aged adults found that eating 35 grams of tomato paste daily for three months improved selective attention and modestly boosted associative memory; brain scans in a subset showed tentative changes in connectivity across large-scale brain networks, suggesting possible neural reorganization, though results are preliminary due to small sample size and unblinded design.
A randomized crossover trial of 108 adults who regularly used cannabis found that inhaling cannabis on 14 days reduced daily cardiac ectopy by about 9%, driven by fewer premature atrial contractions, with no significant changes in premature ventricular contractions, physical activity, sleep, or mean glucose; the effects are small, the study has limitations (imperfect adherence, varied cannabis products, young population with low ectopy), and researchers urge more research before any clinical implications are drawn.
In a 16-week randomized trial, adults with overweight following an ad libitum low-fat vegan diet ate roughly the same amount of food by weight but consumed about 357 fewer calories per day and reduced dietary energy density by ~30%, leading to weight loss without calorie counting or portion control.
A French randomized trial in healthy adults around age 80 found that stopping statins at age 75 did not worsen three-year outcomes compared with continuing them; LDL rose after stopping, but death rates and major cardiovascular events were similar and quality of life remained unchanged. The findings may apply only to low-risk, healthy elderly populations and should not change practice broadly; decisions should be individualized and confirmed with longer follow-up and diverse populations.
In a multicenter, double‑blind randomized trial, nightly dronabinol (THC) reduced PTSD‑related nightmares more than placebo over 10 weeks in 171 adults. The primary outcome (CAPS‑IV B2: nightmare frequency/intensity) favored dronabinol with a between‑group difference of −1.50 (CI −2.28 to −0.71) and a moderate effect size (Cohen’s d ≈ 0.65), supporting dronabinol as a potential pharmacotherapy for PTSD nightmares; safety was monitored during titration and maintenance, and data access is described in the publication.
In the SOLARIS phase 3 trial, 455 patients with previously untreated metastatic colorectal cancer were randomized to high-dose vitamin D3 plus standard chemotherapy with bevacizumab or standard-dose vitamin D3. High-dose vitamin D3 did not improve progression-free survival (11.8 vs 10.3 months), objective response rate, or overall survival, though there was a signal suggesting left-sided tumors may benefit. The regimen was well tolerated with similar adverse events between groups. The findings do not support routine use of high-dose vitamin D3 in unselected patients and warrant further investigation in targeted subgroups.
A Phase III trial of 830 children under six with severe early childhood caries found that a 38% silver diamine fluoride liquid applied to affected teeth significantly slowed decay over eight months, with about 50% showing no progression versus 17% on placebo, supporting FDA approval for noninvasive treatment, though it causes permanent tooth darkening and had similar adverse events to placebo.
A randomized controlled trial in adults with major depression and active suicidal ideation found that a single subanesthetic ketamine infusion increased waking morning cortisol 24 hours post-treatment (not seen with midazolam). This cortisol rise coincided with ketamine’s peak anti-suicidal effects, though the correlation with symptom improvement was modest and not consistently significant. The findings suggest cortisol changes may be involved in ketamine’s action on the stress-response system, but more research with more comprehensive sampling and sleep monitoring is needed to establish causality and clinical relevance.
Two randomized trials suggest Paxlovid, started during acute SARS-CoV-2 infection, reduced the risk of developing long COVID by about 40% at three months, while metformin cut the risk of physician-diagnosed long COVID at six months by roughly half. Experts are cautiously optimistic, but definitions and generalizability vary, and more data are needed to confirm efficacy across diverse populations.
A randomized trial in JAMA Network Open tested intermittent theta-burst stimulation (iTBS) for major depressive disorder. Over a 10-day course, 41 participants received real iTBS and 32 received sham stimulation; iTBS produced greater clinician-rated improvement during treatment, but by four weeks post-treatment the sham group had caught up, and self-reported symptoms showed little difference. The sham coil mimicked sensations to preserve blinding. Overall, findings suggest potential short-term benefits of iTBS but raise questions about durability and the need for longer follow-up in future studies.
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.