scholarly journals Effect of Acute Acai (Euterpe oleracea Mart.) Supplementation on Postprandial Glycaemia in Healthy Adults: A Pilot Randomised Controlled Study

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 853-853
Author(s):  
Kyriaki Myrissa ◽  
Paul Chappell ◽  
Eirini Kelaiditi
Keyword(s):  
Dietary Intervention ◽  
Disease Risk ◽  
Blood Glucose Concentration ◽  
Healthy Adults ◽  
Controlled Study ◽  
Euterpe Oleracea ◽  
Double Blind ◽  
Postprandial Glycaemia ◽  
Significant Difference ◽  
Acai Berry

Abstract Objectives Anthocyanin rich foods may ameliorate postprandial glycaemia. Postprandial glycaemia is associated with Type 2 Diabetes and a risk factor for cardiovascular disease. Acai berry is high in anthocyanins and has received attention for its health benefits. However, human trials are limited. The objective of the present study was to investigate the effect of acai berry extract on postprandial glycaemia responses in healthy adults. Methods Ten healthy participants, aged 18–65 years (mean 33 ± 16), with a body mass index (BMI) of 18.5–24.9 kg/m2 (mean 22.2 ± 1.5) completed a randomized, controlled, double-blind, crossover, acute dietary intervention trial. Participants consumed either an acai-based smoothie (AS) containing 150g acai pulp or a macronutrient-matched control placebo smoothie (PS). The primary endpoint was blood glucose concentration (BGC) which was determined by a capillary sampling method at baseline and at regular intervals up to 2 hours postprandially. Results Consumption of acai resulted in lower mean BGC compared to placebo (5.38 ± 0.46mmol/l vs. 5.40 ± 0.63mmol/l), but this was not significant (p = 0.888), even after controlling for age and BMI. There was no significant difference in BGC incremental area under the curve (iAUC) for acai relative to placebo. Conclusions In this acute study on heathy adults of a wide age range, acai consumption was not associated with improvements in postprandial glycaemia. Future long-term, adequately powered intervention studies, assessing additional biomarkers of disease risk are needed to fully elucidate the benefits of acai to health. Funding Sources None.

scholarly journals A Single-Dose of a Polyphenol-Rich Fucus Vesiculosus Extract is Insufficient to Blunt the Elevated Postprandial Blood Glucose Responses Exhibited by Healthy Adults in the Evening: A Randomised Crossover Trial

Antioxidants ◽  
2019 ◽  
Vol 8 (2) ◽  
pp. 49 ◽  
Author(s):  
Margaret Murray ◽  
Aimee Dordevic ◽  
Lisa Ryan ◽  
Maxine Bonham
Keyword(s):  
Blood Glucose ◽  
Crossover Trial ◽  
Blood Glucose Concentration ◽  
Rice Flour ◽  
Fucus Vesiculosus ◽  
Healthy Adults ◽  
Postprandial Hyperglycaemia ◽  
Postprandial Blood Glucose ◽  
Double Blind ◽  
Postprandial Glycaemia

When healthy adults consume carbohydrates at night, postprandial blood glucose responses are elevated and prolonged compared to daytime.Extended postprandial hyperglycaemia is a risk factor for type 2 diabetes. Polyphenols are bioactive secondary metabolites of plants and algae with potential to moderate postprandial glycaemia. This study investigated whether a polyphenol-rich alga (Fucus vesiculosus) extract moderated postprandial glycaemia in the evening in healthy adults. In a double blind, placebo-controlled, randomised three-way crossover trial, 18 participants consumed a polyphenol-rich extract, a cellulose placebo and rice flour placebo (7:15 p.m.) prior to 50 g available carbohydrate from bread (7:45 p.m.), followed by three hours of blood sampling to assess glucose and insulin. A subset of participants (n = 8) completed the same protocol once in the morning with only the cellulose placebo (7:15 a.m.). No effect of the polyphenol-rich extract was observed on postprandial glycaemia in the evening, compared with placebos, in the group as a whole. However, in females only, peak blood glucose concentration was reduced following the polyphenol-rich extract. In the subset analysis, as expected, participants exhibited elevated postprandial blood glucose in the evening compared with the morning following the cellulose placebo. This was the first study to investigate whether a polyphenol intervention moderated evening postprandial hyperglycaemia. The lowering effect observed in females suggests that this warrants further investigation.

Abstract TP146: Vagus Nerve Stimulation Paired With Rehabilitation To Improve Upper Limb Function

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Jesse Dawson ◽  
Theresa J Kimberley ◽  
Gerard E Francisco ◽  
Patricia Smith ◽  
Steven C Cramer ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Upper Extremity ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Human Study ◽  
Controlled Study ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Upper Limb Function ◽  
Significant Difference

Introduction: Vagus Nerve Stimulation (VNS) paired with rehabilitation induces movement specific plasticity in rat motor cortex and improves forepaw function in a rat ischemic model compared to rehabilitation alone. A 20 subject first-in-human study in the UK indicated acceptable safety and feasibility of this approach in patients with arm weakness after stroke and showed a significant difference in favour of VNS paired with rehabilitation in the per-protocol analysis (Upper Extremity Fugl Meyer difference of 9.6 points for VNS vs. 3.0 Control; p = 0.038). We conducted a new, double-blind sham controlled study to further assess this technique. Methods: Subjects with chronic moderate to severe upper extremity hemiparesis secondary to ischemic stroke (Upper Extremity Fugl Meyer (UEFM) 20-50) were enrolled at four sites (3 US, 1 UK). After baseline assessments subjects were implanted with a vagus nerve stimulation device if all eligibility criteria were met. Following implantation, randomization was made to either paired VNS (1/2 second, 30 Hz., 0.8 mA, 100 uS stimulation with task-specific movement) or sham control (stimulation only on first 5 movements). All received the same intensive and task-specific rehabilitation and had 18 treatment sessions (2-hourly, 3 times a week for 6-weeks, approximately 50 repetitions per task and 300 to 400 repetition movements per session). Outcomes were assessed on the first and 30 th day following completion of the 6-week therapy course. Results: Sixteen patients (8 female) were implanted (8 VNS, 8 Control). Mean age (SD) was 63.2(6.9), with an average (SD) of 21.7 months (12.9) post stroke. One study related serious adverse event was reported (a wound infection that resolved with IV antibiotics). Blinded results (change in UEFM, WMFT, and UEFM responders for both groups) will be available and presented. Conclusions: A pivotal study of VNS paired with rehabilitation movements will be justified if preliminary results are confirmed.

Effects of diets rich in ghee or olive oil on cardiometabolic risk factors in healthy adults: A 2-period, crossover, randomized trial

2021 ◽  
pp. 1-30
Author(s):  
Susan Mohammadi Hosseinabadi ◽  
Javad Nasrollahzadeh
Keyword(s):  
Olive Oil ◽  
Dietary Intervention ◽  
Disease Risk ◽  
Cardiovascular Disease Risk ◽  
Density Lipoprotein ◽  
Dietary Fats ◽  
Lipoprotein Cholesterol ◽  
Apo B ◽  
Blood Samples ◽  
Significant Difference

Abstract This study aimed to evaluate the cardiovascular health-related effects of consuming ghee in the usual diet. Thirty healthy men and women were studied in a free-living outpatient regimen. The participants were instructed for the isocaloric inclusion of ghee or olive oil in their diets for 4 weeks using a randomized crossover design. At the end of run-in (baseline), 2-week wash-out, and interventions, fasting blood samples were drawn. In addition, 2-h postprandial blood samples were collected after ingestion of a meal containing olive oil or ghee at week 4 of each dietary intervention. Body weight was not different between the two interventions. Compared to the olive oil, the diet with ghee increased fasting plasma apolipoprotein-B (apo B) (0.09, 95% CI 0.02 to 0.17 g/L, p= 0.018) and non-high-density lipoprotein cholesterol (non-HDL-C) (0.53, 95% CI 0.01 to 1.05 mmol/L, p= 0.046) and low-density lipoprotein cholesterol did not differ significantly between diet groups (0.29, 95% CI –0.05 to 0.63 mmol/L, p= 0.092), but had no significant effect on total cholesterol/HDL-C ratio (0.75, 95% CI −0.24 to 1.74 mmol/L, p= 0.118). No significant difference was observed in fasting as well as 2-h postprandial plasma triacylglycerol, glucose, insulin, and plasminogen activator inhibitor-1 concentrations. This study showed that ghee which is predominantly saturated fats had an increasing effect on plasma apo B and non-HDL-C compared to olive oil, adding further evidence to the existing recommendations to replace dietary fats high in SFA with dietary fats high in unsaturated fats to reduce cardiovascular disease risk.

scholarly journals Involvement of N-methyl-d-aspartate receptors in plasticity induced by paired corticospinal-motoneuronal stimulation in humans

2018 ◽  
Vol 119 (2) ◽  
pp. 652-661 ◽  
Author(s):  
Siobhan C. Dongés ◽  
Jessica M. D’Amico ◽  
Jane E. Butler ◽  
Janet L. Taylor
Keyword(s):  
Biceps Brachii ◽  
Motor Evoked Potentials ◽  
Controlled Study ◽  
Spinal Level ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Spinal Cord ◽  
Significant Difference ◽  
Antidromic Potentials ◽  
Dependent Mechanism

Plasticity can be induced at human corticospinal-motoneuronal synapses by delivery of repeated, paired stimuli to corticospinal axons and motoneurons in a technique called paired corticospinal-motoneuronal stimulation (PCMS). To date, the mechanisms of the induced plasticity are unknown. To determine whether PCMS-induced plasticity is dependent on N-methyl-d-aspartate receptors (NMDARs), the effect of the noncompetitive NMDAR antagonist dextromethorphan on PCMS-induced facilitation was assessed in a 2-day, double-blind, placebo-controlled experiment. PCMS consisted of 100 pairs of stimuli, delivered at an interstimulus interval that produces facilitation at corticospinal-motoneuronal synapses that excite biceps brachii motoneurons. Transcranial magnetic stimulation elicited corticospinal volleys, which were timed to arrive at corticospinal-motoneuronal synapses just before antidromic potentials elicited in motoneurons with electrical brachial plexus stimulation. To measure changes in the corticospinal pathway at a spinal level, biceps responses to cervicomedullary stimulation (cervicomedullary motor evoked potentials, CMEPs) were measured before and for 30 min after PCMS. Individuals who displayed a ≥10% increase in CMEP size after PCMS on screening were eligible to take part in the 2-day experiment. After PCMS, there was a significant difference in CMEP area between placebo and dextromethorphan days ( P = 0.014). On the placebo day PCMS increased average CMEP areas to 127 ± 46% of baseline, whereas on the dextromethorphan day CMEP area was decreased to 86 ± 33% of baseline (mean ± SD; placebo: n = 11, dextromethorphan: n = 10). Therefore, dextromethorphan suppressed the facilitation of CMEPs after PCMS. This indicates that plasticity induced at synapses in the human spinal cord by PCMS may be dependent on NMDARs. NEW & NOTEWORTHY Paired corticospinal-motoneuronal stimulation can strengthen the synaptic connections between corticospinal axons and motoneurons at a spinal level in humans. The mechanism of the induced plasticity is unknown. In our 2-day, double-blind, placebo-controlled study we show that the N-methyl-d-aspartate receptor (NMDAR) antagonist dextromethorphan suppressed plasticity induced by paired corticospinal-motoneuronal stimulation, suggesting that an NMDAR-dependent mechanism is involved.

scholarly journals 902. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of a Single Immunization of Ad26.RSV.preF against RSV Infection in a Viral Challenge Model in Healthy Adults

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S27-S28 ◽  
Author(s):  
John DeVincenzo ◽  
Efi Gymnopoulou ◽  
Els De Paepe ◽  
Bryan Murray ◽  
Arangassery Rosemary Bastian ◽  
...  
Keyword(s):  
Disease Severity ◽  
Healthy Adults ◽  
Controlled Study ◽  
Clinical Strain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Qrt Pcr ◽  
Rsv Infection ◽  
First Time ◽  
Over Time

Abstract Background Despite the high disease burden of RSV in older adults and children, there is currently no approved vaccine. Ad26.RSV.preF, an experimental RSV vaccine, has demonstrated immunogenicity and tolerability in first-in-human clinical studies. The aim of this study was to assess the potential of the Ad26.RSV.preF vaccine to protect against RSV infection and disease in an established RSV human challenge model, used for the first time to evaluate a vaccine. Methods We conducted a randomized, double-blind, placebo-controlled, human challenge study (NCT03334695). Healthy adults received 1 × 1011 vp Ad26.RSV.preF vaccine (active) or placebo (pbo) intramuscularly. After 28 days, volunteers were challenged intranasally with a low-passage clinical strain of RSV-A (0.8 mL of Memphis 37b) and then quarantined for 12 days. Nasal washes were collected twice daily throughout quarantine, starting 2 days post-challenge (viral load [VL] by qRT-PCR and quantitative cultures). Disease severity was recorded thrice daily using symptom diary cards. Results Fifty-three volunteers (active, n = 27; pbo, n = 26) were challenged with RSV-A. Quantitative viral assessments were consistently lower in active than pbo. The primary endpoint of the study was met: the area under the curve (AUC) for RSV VL over time (via qRT-PCR) was significantly lower in active pbo (P = 0.012). Median peak VL was lower for active (0 log10 copies/mL) than pbo (5.4 log10 copies/mL). Median AUC for RSV VL over time (quantitative culture) was lower for active than pbo (0 vs. 109, P = 0.002). Disease severity was lower for active than pbo, with a median AUC total symptom score of 35 (active) vs. 167 (pbo) (P = 0.002). Overall, RSV infection (defined by qRT-PCR alone or combined with symptoms) and disease severity over time were lower in active vs. pbo. Conclusion RSV infections, VL, and RSV disease severity were consistently lower in healthy adults receiving Ad26.RSV.preF vs. placebo, demonstrating promising protection from RSV infection and disease. This was the first time that antiviral prevention was observed against RSV after active immunization. Ad26.RSV.preF warrants further evaluation in field trials for efficacy against natural RSV infections in populations considered at risk of severe RSV disease. Disclosures All Authors: No reported Disclosures.

scholarly journals A double-blind randomized placebo-controlled study of low dose mirtazapine once daily in patients of major depressive disorders on escitalopram

2019 ◽  
Vol 8 (5) ◽  
pp. 1067
Author(s):  
Mallikarjuna Rao I. ◽  
Usha Kiran Prayaga ◽  
Dharma Rao Uppada ◽  
Ramachandra Rao E. ◽  
B. L. Kudagi
Keyword(s):  
Depressive Disorders ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Study ◽  
P Value ◽  
Chi Square ◽  
Double Blind ◽  
Increased Risk ◽  
Significant Difference ◽  
Chi Square Test

Background: The SSRIs being used as 1st line therapy in treatment of depression have delayed therapeutic effect which makes the patient vulnerable to an increased risk of suicide and decreased adherence to the treatment and will prematurely discontinue the therapy. The present study was conducted to evaluate if low dose mirtazapine-escitalopram combination therapy has any add on benefit over monotherapy with escitalopram.Methods: In a single-centered, comparative study involving patients with depression attending the out-patient after screening and exclusion, 60 eligible patients were randomly assigned to receive tablet mirtazapine 7.5 mg plus tablet escitalopram 10 mg intervention or tablet escitalopram 10 mg plus placebo intervention in a double-blind 6-week treatment phase. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS) and Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline. Participants were evaluated at baseline, 1st, 2nd,4th and 6th week. Results were analyzed using Chi-Square test for adverse effects and independent t-test analysis for efficacy parameter.Results: In the analysis of results at 6th week the numbers of patients achieved remission in mirtazapine group are more with a p-value of 0.018 which is significant and the numbers of responders in mirtazapine group are also more which is statistically significant on chi-square test. There is no significant difference was observed between the two groups with reference to occurrence of adverse effect.Conclusions: Adding low dose mirtazapine has an added benefit in terms of efficacy and getting remission early with more number of responders in the treatment of major depression.

scholarly journals Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽  
2018 ◽  
Vol 67 (12) ◽  
pp. 2107-2115 ◽  
Author(s):  
Sofie Ingdam Halkjær ◽  
Alice Højer Christensen ◽  
Bobby Zhao Sheng Lo ◽  
Patrick Denis Browne ◽  
Stig Günther ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Controlled Study ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Faecal Samples ◽  
Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

Economic evaluation of the randomised, double-blind, placebo-controlled study of subcutaneous ketamine in the management of chronic cancer pain

2018 ◽  
Vol 33 (1) ◽  
pp. 74-81 ◽  
Author(s):  
Nikki McCaffrey ◽  
Thomas Flint ◽  
Billingsley Kaambwa ◽  
Belinda Fazekas ◽  
Debra Rowett ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cost Effectiveness ◽  
Cancer Pain ◽  
Sensitivity Analyses ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cost Effective Treatment ◽  
Significant Difference ◽  
The Cost

Background: Treating chronic, uncontrolled, cancer pain with subcutaneous ketamine in patients unresponsive to opioids and co-analgesics remains controversial, especially in light of recent evidence demonstrating ketamine does not have net clinical benefit in this setting. Aim: To evaluate the cost-effectiveness of subcutaneous ketamine versus placebo in this patient population. Design and setting: A within-trial cost-effectiveness analysis of the Australian Palliative Care Clinical Studies Collaborative’s randomised, double-blind, placebo-controlled trial of ketamine was conducted from a healthcare provider perspective. Mean costs and outcomes were estimated from participant-level data over 5 days including positive response, health-related quality of life (HrQOL) measured with the Functional Assessment of Chronic Illness Therapy–Palliative Care (FACIT-Pal), ketamine costs, medication usage and in-patient stays. Results: There was no statistically significant difference in responder rates, but higher toxicity and worse HrQOL for ketamine participants (mean change −3.10 (standard error (SE) 1.76), ketamine n = 93; 4.53 (SE 1.38), placebo n = 92). Estimated total mean costs were AU$706 higher per ketamine participant (AU$6608) compared with placebo (AU$5902), attributable to the cost of higher in-patient costs as well as costs of ketamine administration. The results were robust to sensitivity analyses accounting for different medication use costing methods and removal of cost outliers. Conclusion: The findings suggest subcutaneous ketamine in conjunction with opioids and standard adjuvant therapy is neither an effective nor cost-effective treatment for refractory pain in advanced cancer patients.

scholarly journals A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 296
Author(s):  
Irina Kiseleva ◽  
Irina Isakova-Sivak ◽  
Marina Stukova ◽  
Marianna Erofeeva ◽  
Svetlana Donina ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Phase 1 ◽  
Healthy Adults ◽  
Controlled Study ◽  
Temperature Sensitive ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Human Influenza Virus ◽  
Live Attenuated Influenza Vaccine

This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

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