Moringa oleifera Leaf Supplementation as a Glycemic Control Strategy in Subjects with Prediabetes

Moringa oleifera (MO) is a multipurpose plant with a high polyphenol content, which is being increasingly consumed to lessen the risk of chronic metabolic diseases such as Type 2 diabetes; however, scientific evidence from clinical trials is scarce. A double-blind, randomized, placebo-controlled, parallel group intervention study with MO leaves as a food supplement was conducted in subjects with prediabetes. They consumed six daily capsules of MO dry leaf powder (2400 mg/day) (MO, n = 31) or placebo (PLC, n = 34) over 12 weeks. Glycemia, appetite-controlling hormones and gut microbiota composition were studied. ANCOVA with the fixed factor “treatment” and the basal value as covariate was used to compare the change score between the groups. The results showed significant differences between groups in the rate of change of fasting blood glucose (FBG) and glycated hemoglobin (HbA1c), which showed opposite directions during the intervention, decreasing in MO and increasing in PLC. No different change scores were found between the groups in microbiota, hepatic and renal function markers or the appetite-controlling hormones measured. In conclusion, MO supplementation resulted in favorable changes in glycaemia markers compared to placebo in the subjects with prediabetes studied, suggesting that MO might act as a natural antihyperglycemic agent.

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Acetyl L-Carnitine Slows Decline in Younger Patients With Alzheimer's Disease: A Reanalysis of a Double-Blind, Placebo-Controlled Study Using the Trilinear Approach

International Psychogeriatrics ◽

10.1017/s1041610298005304 ◽

1998 ◽

Vol 10 (2) ◽

pp. 193-203 ◽

Cited By ~ 33

Author(s):

John O. Brooks ◽

Jerome A. Yesavage ◽

Angelico Carta ◽

Daniele Bravi

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Average Rate ◽

The United States ◽

Rate Of Change ◽

Disease Assessment ◽

Controlled Study ◽

Double Blind ◽

Parallel Group ◽

Longitudinal Effects

Objectives: To assess the longitudinal effects of acetyl-L-carnitine (ALC) on patients diagnosed with Alzheimer's disease. Design: Longitudinal, double-blind, parallel-group, placebocontrolled. Setting: Twenty-four outpatient sites across the United States. Participants: A total of 334 subjects diagnosed with probable Alzheimer's disease by NINCDS-ADRDA criteria. These data were originally reported by Thal and colleagues (1996). Measurements: Cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS) given every 3 months for 1 year. Results: The average rate of change was estimated using the trilinear approach, which allows for periods of both change and stability. Both the ALC group and the placebo group exhibited the same mean rate of change on the ADAS (0.68 points/month). However, a multiple regression analysis revealed a statistically significant Age × Drug interaction characterized by younger subjects benefiting more from ALC treatment than older subjects. Further analyses suggested that the optimal, though not statistically significant, cutpoint for ALC benefit was 61 years of age. Conclusions: ALC slows the progression of Alzheimer's disease in younger subjects, and the use of the trilinear approach to estimate the average rate of change may prove valuable in pharmacological trials.

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A Comparative Study of a New Food Supplement, ViviScal®, with Fish Extract for the Treatment of Hereditary Androgenic Alopecia in Young Males

Journal of International Medical Research ◽

10.1177/030006059202000601 ◽

1992 ◽

Vol 20 (6) ◽

pp. 445-453 ◽

Cited By ~ 10

Author(s):

A Lassus ◽

E Eskelinen

Keyword(s):

Treatment Group ◽

Food Supplement ◽

Androgenic Alopecia ◽

Double Blind ◽

Once Daily ◽

Young Males ◽

Highly Active ◽

Parallel Group ◽

The Mean

A controlled, randomized, double-blind, parallel-group study compared the effects of ViviScal® (a new food supplement incorporating special marine extracts and a silica compound) with those of a fish extract in the treatment of young males with hereditary androgenic alopecia. The pretreatment histological diagnosis was alopecia with a mild to moderate perifollicular inflammation zone. The study consisted of 20 subjects who received two tablets of ViviScal® once daily and 20 who received two tablets of fish extract once daily for 6 months. The mean patient age and mean duration and severity of baldness compared well between the two groups. Most patients had been treated with long-term topical 2% minoxidil for 1 year or more prior to the study. At baseline and after 6 months' treatment, a biopsy was taken for histological examination. A non-vellus hair count was performed at baseline and after 2, 4 and 6 months. In the fish extract treatment group three patients withdrew from the study before the fourth month due to lack of therapeutic effect. After 6 months' treatment, patients receiving ViviScal® showed a mean increase in non-vellus hair of 38% compared with a 2% increase in the fish extract treatment group (P < 0.0001). In the ViviScal® group, 19 (95%) subjects showed both clinical and histological cure, whereas none treated with fish extract showed any clinical or histological difference after 6 months' treatment ( P < 0.0001). In both groups, a minimal decrease in the erythemal index was observed. In conclusion, ViviScal® appears to be the first highly active treatment for androgenic alopecia in young males.

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PANTHEON-II: The peripheral effects of prednisolone on glucose metabolism, metabolic hormones, insulin sensitivity and insulin secretion in healthy young males and males with metabolic syndrome: a randomised, placebo controlled, double blind, dose-response, parallel group intervention study

http://isrctn.org/> ◽

10.1186/isrctn83991850 ◽

2012 ◽

Author(s):

Michaela Diamant

Keyword(s):

Metabolic Syndrome ◽

Insulin Secretion ◽

Insulin Sensitivity ◽

Glucose Metabolism ◽

Group Intervention ◽

Intervention Study ◽

Double Blind ◽

Young Males ◽

Metabolic Hormones ◽

Parallel Group

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Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia: A Double-blind, Randomised Placebo-controlled Clinical Trial

European Psychiatry ◽

10.1016/s0924-9338(09)71388-4 ◽

2009 ◽

Vol 24 (S1) ◽

pp. 1-1

Author(s):

D. Koethe ◽

L. Kranaster ◽

M. Hellmich ◽

B.M. Nolden ◽

J. Klosterkoetter

Keyword(s):

Rating Scale ◽

Rate Of Change ◽

Controlled Clinical Trial ◽

Antipsychotic Therapy ◽

Double Blind ◽

Parallel Group ◽

Significant Difference ◽

Mixed Regression ◽

Psychiatric Rating ◽

Psychiatric Rating Scale

The outcome in treatment of schizophrenia is still not satisfactorily, and using the adjunctive administration of various anticonvulsant drugs adjunctive to antipsychotics has become widely distributed. This study determines the efficacy of oxcarbazepine combined to olanzapine in treatment of schizophrenia in a double-blind, randomized, placebo-controlled, parallel-group, add-on therapy, 7 week study in 54 patients suffering schizophreniform disorder or schizophrenia. Patients were randomized to oxcarbazepine or placebo and titrated up to 1800 mg/ day in week 1 and maintained at that dose for another 6 weeks. Treatment of olanzapine started at week 2 with 5 mg/day. According to weekly improvement in Brief Psychiatric Rating Scale (BPRS), olanzapine dose was maintained constant or escalated in regular steps of 2.5 mg. Main outcome measure was the cumulative olanzapine dose from beginning administration of oxcarbazepine/placebo for a period of 42 days. Comparing treatment of oxcarbazepine and olanzapine with placebo and olanzapine, there was no difference in cumulative olanzapine doses in both groups. in the oxcarbazepine group was not significantly more rescue medication given. A mixed regression model was used to assess time trends in BPRS over the treatment period: the differences in the rate of change of BPRS in the two treatment groups suggested that the scores sank more rapidly in the oxcarbazepine group (p=0.063). Mean post-treatment aggression score also showed no significant difference. Results from this study do not support the use of OXC as an adjunct to atypical antipsychotics in patients with schizophrenia.

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PANTHEON-I: The peripheral effects of prednisolone on glucose metabolism, metabolic hormones, insulin sensitivity and insulin secretion in healthy young males and males with metabolic syndrome: a randomised, placebo controlled, double blind, dose-response, parallel group intervention study

http://isrctn.org/> ◽

10.1186/isrctn78149983 ◽

2013 ◽

Author(s):

Michaela Diamant

Keyword(s):

Metabolic Syndrome ◽

Insulin Secretion ◽

Insulin Sensitivity ◽

Glucose Metabolism ◽

Group Intervention ◽

Intervention Study ◽

Double Blind ◽

Young Males ◽

Metabolic Hormones ◽

Parallel Group

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STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease

The Journal of Rheumatology ◽

10.3899/jrheum.191365 ◽

2020 ◽

pp. jrheum.191365

Author(s):

Dinesh Khanna ◽

Donald P. Tashkin ◽

Athol U. Wells ◽

James R. Seibold ◽

Stephen Wax ◽

...

Keyword(s):

Systemic Sclerosis ◽

Interstitial Lung Disease ◽

Lung Disease ◽

Phase Ii ◽

Phase Ii Study ◽

Multicenter Trial ◽

Rate Of Change ◽

Double Blind ◽

Parallel Group ◽

To Receive

Objective To investigate the effects of abituzumab in systemic sclerosis-associated interstitial lung disease (SSc-ILD). Methods STRATUS was a Phase II, double-blind, parallel-group, multicenter trial (NCT02745145). Adults (≤75 years) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, placebo, or abituzumab 500 mg every 4 weeks for 104 weeks. Primary endpoint: annual rate of change in absolute FVC. Results STRATUS was terminated prematurely due to slow enrolment (n=75 screened, n=24 randomized), precluding robust analysis of efficacy. Abituzumab was well-tolerated; no new safety signals were detected. Conclusion Further investigation of abituzumab for treatment of SSc-ILD is required.

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Spontaneous and deliberate creative cognition during and after psilocybin exposure

Translational Psychiatry ◽

10.1038/s41398-021-01335-5 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

N. L. Mason ◽

K. P. C. Kuypers ◽

J. T. Reckweg ◽

F. Müller ◽

D. H. Y. Tse ◽

...

Keyword(s):

Creative Thinking ◽

Scientific Evidence ◽

Network Connectivity ◽

Everyday Functioning ◽

Double Blind ◽

Creative Cognition ◽

Parallel Group Design ◽

Parallel Group ◽

Psychedelic Drugs ◽

Broad Interest

AbstractCreativity is an essential cognitive ability linked to all areas of our everyday functioning. Thus, finding a way to enhance it is of broad interest. A large number of anecdotal reports suggest that the consumption of psychedelic drugs can enhance creative thinking; however, scientific evidence is lacking. Following a double-blind, placebo-controlled, parallel-group design, we demonstrated that psilocybin (0.17 mg/kg) induced a time- and construct-related differentiation of effects on creative thinking. Acutely, psilocybin increased ratings of (spontaneous) creative insights, while decreasing (deliberate) task-based creativity. Seven days after psilocybin, number of novel ideas increased. Furthermore, we utilized an ultrahigh field multimodal brain imaging approach, and found that acute and persisting effects were predicted by within- and between-network connectivity of the default mode network. Findings add some support to historical claims that psychedelics can influence aspects of the creative process, potentially indicating them as a tool to investigate creativity and subsequent underlying neural mechanisms. Trial NL6007; psilocybin as a tool for enhanced cognitive flexibility; https://www.trialregister.nl/trial/6007.

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