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1.
Oral Pycnogenol® Intake Benefits the Skin in Urban Chinese Outdoor Workers: A Randomized, Placebo-Controlled, Double-Blind, and Crossover Intervention Study.
Zhao, H, Wu, J, Wang, N, Grether-Beck, S, Krutmann, J, Wei, L
Skin pharmacology and physiology. 2021;(3):135-145
Abstract
BACKGROUND Oral supplementation with a standardized extract from the bark of the French pine (Pycnogenol®) has been reported to benefit the skin. It might thus represent an easy-to-use strategy to improve the skin health of individuals who are exposed to considerable environmental stress in large urban areas. OBJECTIVE We investigated if oral intake of Pycnogenol® can benefit the skin of Han Chinese working outdoors in Beijing, China. METHODS In a monocentre, double-blind, randomized, placebo-controlled, and crossover study, the effects of Pycnogenol® intake (2 × 50 mg/day for a total of 12 weeks) on a variety of skin physiological parameters was studied in Chinese subjects (n = 76), from spring to autumn, who were working outdoors in Beijing, China. RESULTS During the intervention period, study subjects were constantly exposed to increased levels of particulate matter (PM)2.5 as well as seasonal changes in humidity and temperature. Despite this environmental stress, Pycnogenol® intake prevented (i) a decrease in the skin hydration, (ii) transepidermal water loss (TEWL), and (iii) skin darkening during the dry autumn season. In addition, Pycnogenol® intake improved (iv) viscoelastic skin properties such as gross elasticity and elastic recovery irrespective of the season. These beneficial effects were not observed if the same subjects were supplemented with placebo. CONCLUSION Oral intake of Pycnogenol® benefits the skin in Han Chinese, who are working outdoors under considerable environmental stress.
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2.
Effects of 12 Weeks Cosmos caudatus Supplement among Older Adults with Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo-Controlled Trial.
You, YX, Shahar, S, Rajab, NF, Haron, H, Yahya, HM, Mohamad, M, Din, NC, Maskat, MY
Nutrients. 2021;(2)
Abstract
Cosmos caudatus (CC) contains high flavonoids and might be beneficial in neuroprotection. It has the potential to prevent neurodegenerative diseases. Therefore, we aimed to investigate the effects of 12 weeks of Cosmos caudatus supplement on cognitive function, mood status, blood biochemical profiles and biomarkers among older adults with mild cognitive impairment (MCI) through a double-blind, placebo-controlled trial. The subjects were randomized into CC supplement (n = 24) and placebo group (n = 24). Each of them consumed one capsule of CC supplement (250 mg of CC/capsule) or placebo (500 mg maltodextrin/capsule) twice daily for 12 weeks. Cognitive function and mood status were assessed at baseline, 6th week, and 12th week using validated neuropsychological tests. Blood biochemical profiles and biomarkers were measured at baseline and 12th week. Two-way mixed analysis of variance (ANOVA) analysis showed significant improvements in mini mental state examination (MMSE) (partial η2 = 0.150, p = 0.049), tension (partial η2 = 0.191, p = 0.018), total mood disturbance (partial η2 = 0.171, p = 0.028) and malondialdehyde (MDA) (partial η2 = 0.097, p = 0.047) following CC supplementation. In conclusion, 12 weeks CC supplementation potentially improved global cognition, tension, total mood disturbance, and oxidative stress among older adults with MCI. Larger sample size and longer period of intervention with incorporation of metabolomic approach should be conducted to further investigate the underlying mechanism of CC supplementation in neuroprotection.
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3.
Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial.
Villar-López, M, Soto-Becerra, P, Curse Choque, R, Al-Kassab-Córdova, A, Bernuy-Barrera, F, Palomino, H, Rojas, PA, Vera, C, Lugo-Martínez, G, Mezones-Holguín, E
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2021;(10):906-913
Abstract
OBJECTIVE To evaluate the safety and tolerability of an oral herbal supplement containing glucosinolates, phytosterols, and citrus flavonoids (Warmi®, Lima Perú;) in otherwise healthy adult women. METHODS This was a phase-I, randomized parallel three arms, double-blinded, and a placebo-controlled clinical trial. A total of 55 participants aged 18-40 were randomly assigned to one of three groups to receive for three months: (1) an oral herbal supplement of 1650 mg/day; (2) an oral herbal supplement of 3300 mg/day; or (3) an oral placebo 3300 mg/day. The primary endpoints were oral safety and tolerability of the supplement. The secondary endpoint was its effect on vital functions, anthropometrics, and laboratory tests. We used an exploratory approach by covariance analysis (ANCOVA) adjusted for the variables' baseline value for the secondary outcomes. RESULTS All women completed three months of follow-up, reporting no side effects. Our exploratory analysis revealed that treatment with the herbal supplement of 1650 mg/day was associated with increased glucose and uric acid levels. In comparison, the herbal supplement 3300 mg/day was associated with reduced breathing rate, increased basal temperature, and systolic blood pressure, both compared to the placebo group. However, despite significant differences, none of these was clinically significant. CONCLUSION The oral herbal supplement had a favorable safety and tolerability profile in studied women. There is a need to study its potential as an option to treat menopausal symptoms.
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4.
The effect of French maritime pine bark extract supplementation on inflammation, nutritional and clinical status in critically ill patients with traumatic brain injury: A randomized controlled trial.
Malekahmadi, M, Shadnoush, M, Islam, SMS, Shirvani, A, Pahlavani, N, Gholizadeh Navashenaq, J, Firouzi, S, McVicar, J, Nematy, M, Zali, MR, et al
Phytotherapy research : PTR. 2021;(9):5178-5188
Abstract
Inflammation plays an important role in the pathophysiology of traumatic brain injury (TBI). Based on the anti-inflammatory properties of French maritime pine bark extract and the neuroprotective effects, we aimed to evaluate the effects of its supplementation on TBI. Sixty-seven TBI patients admitted to the intensive care units (ICUs) were enrolled. After stabilizing the hemodynamic status, the intervention group received 150 mg of French maritime pine bark extract supplementation (Oligopin) with enteral nutrition for 10 days. The control group received a placebo. Inflammatory status and oxidative stress markers were measured three times. Also, clinical and nutritional statuses were assessed. Supplementation, significantly decreased IL-6 (β = -53.43 pg/ml, 95% confidence interval [CI] = -91.74, -15.13, p = .006), IL-1β (β = -111.66 pg/ml, 95% CI = -183.79, -39.5402, p = .002) and C-reactive protein (β = -19.99 mg/L, 95% CI = -27.23, -12.76, p ˃ .001) in the intervention group compared to control group after 10 days. Clinical scores including acute physiology and chronic health evaluation II and sequential organ failure assessment were reduced (β = -3.72, 95% CI = -5.96, -1.49, p = .001and β = -2.07, 95% CI = -3.23, -0.90, p < .001, respectively), and Nutric score was reduced compared to control group (β = -.60, 95% CI = -1.08, -0.12, p = .01). The survival rate was higher by 15% in the intervention group compared to control group. Oligopin supplementation in TBI patients in ICU reduced inflammation and improved the clinical status and malnutrition score and thereby reducing the mortality rate.
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5.
A Double-Blind, Cross-Over Study to Examine the Effects of Maritime Pine Extract on Exercise Performance and Postexercise Inflammation, Oxidative Stress, Muscle Soreness, and Damage.
Aldret, RL, Bellar, D
Journal of dietary supplements. 2020;(3):309-320
Abstract
The purpose of the present study was to examine whether 14 days of supplementation with maritime pine extract leading up to and following an exercise test would increase performance and reduce biomarkers associated with muscle damage, inflammation, and oxidative stress. The study used a double-blind, placebo-controlled, cross-over design. Twenty apparently healthy young male participants ingested either 800 mg pine bark extract or placebo for 14 days prior to the first exercise trial and for 2 days postexercise. On the exercise day, participants submitted a pre-exercise blood sample then completed a VO2 peak test until volitional failure. A postexercise blood sample was collected 1 hour after completion of exercise. Participants returned at 24 and 48 hours after the exercise testing for measures of muscle pain in the lower body using an algometer. Participants then had a 7-day washout period before beginning to cross over to the alternate treatment. Analysis via ordinal regression demonstrated a significant difference in oxidative stress in the maritime pine extract group compared to placebo (ChiSq = 2.63; p = 0.045). Maritime pine extract was effective at affording protection from oxidative stress postexercise. Further work should be undertaken to evaluate the findings with other exercise modes or in participants with known metabolic syndrome.
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Effects of Cocoa-Rich Chocolate on Blood Pressure, Cardiovascular Risk Factors, and Arterial Stiffness in Postmenopausal Women: A Randomized Clinical Trial.
Garcia-Yu, IA, Garcia-Ortiz, L, Gomez-Marcos, MA, Rodriguez-Sanchez, E, Agudo-Conde, C, Gonzalez-Sanchez, J, Maderuelo-Fernandez, JA, Recio-Rodriguez, JI
Nutrients. 2020;(6)
Abstract
This study aimed to evaluate the effects of the intake of 10 g of cocoa-rich chocolate on blood pressure, other cardiovascular risk factors, and vascular structure and function in postmenopausal women. A total of 140 postmenopausal women participated in this randomized and controlled parallel clinical trial. For six months, the intervention group (IG; n = 73) consumed daily 10 g of chocolate (99% cocoa) added to their usual food intake, whereas the control group (CG; n = 67) did not receive any intervention. Blood pressure, pulse pressure (PP), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), augmentation index, and laboratory variables were measured at baseline and six months. ANCOVA analyses adjusted for baseline values revealed no significant differences for systolic blood pressure (-1.45 mm Hg; 95% confidence interval (CI): -4.79, 1.88; p = 0.391) or baPWV (0.18 m/s; 95% CI: -0.14, 0.50; p = 0.263) between groups. A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02; p = 0.048). The rest of the vascular structure and function parameters and other measured variables remained unchanged. The daily intake of 10 g of cocoa-rich chocolate seems to provide little improvement to cardiovascular health, but neither does it cause any adverse effects on the parameters evaluated in postmenopausal women in the long term.
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7.
Acute Ingestion of a Mixed Flavonoid and Caffeine Supplement Increases Energy Expenditure and Fat Oxidation in Adult Women: A Randomized, Crossover Clinical Trial.
Nieman, DC, Simonson, A, Sakaguchi, CA, Sha, W, Blevins, T, Hattabaugh, J, Kohlmeier, M
Nutrients. 2019;(11)
Abstract
This randomized, double-blinded, crossover study measured the acute effect of ingesting a mixed flavonoid-caffeine (MFC) supplement compared to placebo (PL) on energy expenditure (EE) and fat oxidation (FATox) in a metabolic chamber with premenopausal women (n = 19, mean ± SD, age 30.7 ± 8.0 year, BMI 25.7 ± 3.4 kg/m2). The MFC supplement (658 mg flavonoids, split dose 8:30, 13:00) contained quercetin, green tea catechins, and anthocyanins from bilberry extract, and 214 mg caffeine. Participants were measured twice in a metabolic chamber for a day, four weeks apart, with outcomes including 22 h EE (8:30-6:30), substrate utilization from the respiratory quotient (RQ), plasma caffeine levels (16:00), and genotyping for the single-nucleotide polymorphism (SNP) rs762551. Areas under the curve (AUC) for metabolic data from the MFC and PL trials were calculated using the trapezoid rule, with a mixed linear model (GLM) used to evaluate the overall treatment effect. The 22 h oxygen consumption and EE were significantly higher with MFC than PL (1582 ± 143, 1535 ± 154 kcal/day, respectively, p = 0.003, trial difference of 46.4 ± 57.8 kcal/day). FATox trended higher for MFC when evaluated using GLM (99.2 ± 14.0, 92.4 ± 14.4 g/22 h, p = 0.054). Plasma caffeine levels were significantly higher in the MFC versus PL trial (5031 ± 289, 276 ± 323 ng/mL, respectively, p < 0.001). Trial differences for 22 h EE and plasma caffeine were unrelated after controlling for age and body mass (r = -0.249, p = 0.139), and not different for participants with the homozygous allele 1, A/A, compared to C/A and C/C (p = 0.50 and 0.56, respectively). In conclusion, EE was higher for MFC compared to PL, and similar to effects estimated from previous trials using caffeine alone. A small effect of the MFC on FATox was measured, in contrast to inconsistent findings previously reported for this caffeine dose. The trial variance for 22 h EE was not significantly related to the variance in plasma caffeine levels or CYP1A2*1F allele carriers and non-carriers.
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A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis.
Coe, S, Cossington, J, Collett, J, Soundy, A, Izadi, H, Ovington, M, Durkin, L, Kirsten, M, Clegg, M, Cavey, A, et al
Journal of neurology, neurosurgery, and psychiatry. 2019;(5):507-513
Abstract
UNLABELLED The impact of flavonoids on fatigue has not been investigated in relapsing and remitting multiple sclerosis (RRMS). OBJECTIVE To determine the feasibility and estimate the potential effect of flavonoid-rich cocoa on fatigue and fatigability in RRMS. METHODS A randomised double-blind placebo-controlled feasibility study in people recently diagnosed with RRMS and fatigue, throughout the Thames Valley, UK (ISRCTN69897291). During a 6-week intervention participants consumed a high or low flavonoid cocoa beverage daily. Fatigue and fatigability were measured at three visits (weeks 0, 3 and 6). Feasibility and fidelity were assessed through recruitment and retention, adherence and a process evaluation. RESULTS 40 people with multiple sclerosis (10 men, 30 women, age 44±10 years) were randomised and allocated to high (n=19) or low (n=21) flavonoid groups and included in analysis. Missing data were <20% and adherence to intervention of allocated individuals was >75%. There was a small effect on fatigue (Neuro-QoL: effect size (ES) 0.04, 95% CI -0.40 to 0.48) and a moderate effect on fatigability (6 min walk test: ES 0.45, 95% CI -0.18 to 1.07). There were seven adverse events (four control, three intervention), only one of which was possibly related and it was resolved. CONCLUSION A flavonoid beverage demonstrates the potential to improve fatigue and fatigability in RRMS.
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Three-arm, placebo-controlled, randomized clinical trial evaluating the metabolic effect of a combined nutraceutical containing a bergamot standardized flavonoid extract in dyslipidemic overweight subjects.
Cicero, AFG, Fogacci, F, Bove, M, Giovannini, M, Borghi, C
Phytotherapy research : PTR. 2019;(8):2094-2101
Abstract
Our double-blind, placebo-controlled, parallel-group, dose-escalation, clinical trial aimed to test the effect of a combined nutraceutical containing bergamot extract (120-mg flavonoids), phytosterols, vitamin C, and chlorogenic acid from dry artichoke extract on 90 overweight dyslipidemic subjects. Participants were randomly allocated to treatment with two pills of either active treatment or placebo, or a combination of both (a pill per treatment). After 8 weeks, all active-treated groups experienced a significant improvement in triglycerides (TG) versus placebo and in low-density lipoprotein cholesterol (LDL-C) versus baseline and placebo treatments. In the high-dose-treated group, also total cholesterol (TC), nonhigh-density lipoprotein cholesterol (non-HDL-C), γ-glutamil transpeptidasi, high-sensitivity C-reactive protein (hs-CRP), and tumor necrosis factor-α (TNF-α) significantly decreased. At 24-week follow-up, TG levels maintained lower than baseline in all groups. All patients allocated to either low-dose or high-dose active treatment experienced a significant decrease in TG, LDL-C, and homeostatin model assessment of insulin resistance. In subjects taking high-dose active treatment, adiponectin significantly increased, whereas TC, non-HDL-C, insulin (fasting plasma insulin), leptin, leptin/adiponectin ratio, hs-CRP, and TNF-α were significantly reduced. The tested nutraceutical showed to improve lipid and glucose metabolism, adipokines pattern, and systemic inflammation in dyslipidemic overweight subjects.
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10.
High Flavonoid Cocoa Supplement Ameliorates Plasma Oxidative Stress and Inflammation Levels While Improving Mobility and Quality of Life in Older Subjects: A Double-Blind Randomized Clinical Trial.
Munguia, L, Rubio-Gayosso, I, Ramirez-Sanchez, I, Ortiz, A, Hidalgo, I, Gonzalez, C, Meaney, E, Villarreal, F, Najera, N, Ceballos, G
The journals of gerontology. Series A, Biological sciences and medical sciences. 2019;(10):1620-1627
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Abstract
BACKGROUND The age-related decline in mass, strength, and performance of skeletal muscle is associated with loss of independence, falls risk, disability, institutionalization, and death. METHODS To determine whether a cocoa supplement enriched in flavonoids can improve plasma markers of oxidative stress and inflammation, physical performance and frailty in middle-aged and older subjects, we conducted a two-phase, randomized, double-blind, clinical trial. The initial study included 60 subjects (55- to 70-year-old) allocated into placebo (P), highly alkalinized (no-flavonoid; NF), or flavonoid-rich natural cocoa (F) beverage groups. The follow-up study included 74 older subjects (65- to 90-year-old) randomly distributed into NF or F groups. Subjects were instructed to consume the beverages once/day for up to 12-weeks. A comprehensive (aging relevant) set of end points were assessed, which included mean change in blood plasma metabolic and oxidative stress indicators, in physical performance tests and quality of life (QoL). RESULTS In the initial study, the F group showed improved glycemia, triglyceridemia, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, triglyceridemia/HDL index, and oxidative markers. Performance on the Up and Go test, skeletal muscle index, and quality of life also improved. In the follow-up study, F treatment was associated with significant improvements in metabolic, oxidative stress, and inflammatory endpoints and positive effects on physical performance, frailty indicators, and quality of life (F vs. NF group). CONCLUSIONS Regular flavonoids consumption positively affects blood oxidative stress and inflammation end points, cardiometabolic risk markers, physical performance, and quality of life. The sum of such effects may help to mitigate the extent of frailty development in the elderly people. TRIAL REGISTRATION NCT03585868.