4.4 g Oligo Fucoidan powder by six months, BID

Advanced Hepatocellular Carcinoma

Oligo Fucoidan

Placebo

Fudan University Zhongshan Hospital

Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)

Disease Control Rate will be evaluated by RECIST version 1.1

Objective Response Rate will be evaluated using measurements according to RECISTversion 1.1

Overall Survival Rate will be evaluated using measurements according to RECIST version 1.1

Progression Free Survival will be evaluated using measurements according to RECIST version 1.1

Quality of Life will be evaluated by questionnaire based on EORTC-QLQ30, specific questions evaluated by scores from 1 (not at all), 2 (a little), 3 (quite a bit), 4 (very much); overall healthy and quality of life will be evalauted by scores from 1 (very poor) to 7 (excellent)

Hi-Q Marine Biotech International, Ltd.

Subjects will consume 25mg ergothioneine (capsule), 3 times weekly (Monday, Wednesday, and Friday) for a total of 52 weeks.

Subjects will be given placebo (99% microcrystalline cellulose, 1% magnesium stearate; capsule), 3 times weekly (Monday, Wednesday, and Friday) for a total of 52 weeks.

Mild Cognitive Impairment

Ergothioneine is naturally occurring thiol compound obtained solely from diet in humans. Ergothioneine is widely reported to be a natural antioxidant and anti-inflammatory compound. In addition we hypothesize that this compound will be beneficial in improving cognition.

ergothioneine

Placebo. Study control (99% microcrystalline cellulose)

placebo

National University Cancer Institute, Singapore

Investigating the Efficacy of Ergothioneine to Delay Cognitive Decline

Investigating the Efficacy of Ergothioneine to Delay Cognitive Decline in Mild Cognitively Impaired Subjects

30 point questionnaire to test for cognitive function (scoring of cognitive impairment). For the intervention group no change or an increase in test score is expected compared with placebo control. The aggregated scores from the battery of cognitive function assessments (primary outcomes 1 to 8) will be assessed by a panel of psychological consultants to give an overall assessment of cognitive function.

Numerical scale used to characterize the severity of dementia. Assesses the six domains of cognitive and functional performance applicable to dementia; Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. For clinical dementia rating a decrease in CDR scale is expected.

The Rey Auditory Verbal Learning Test (RAVLT) evaluates short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the client must again repeat the original list of 15 words and then again after 30 minutes.

The digit span task is a measure of working memory, based on a person's ability to recall a sequence of numerical digits. An increase or no change in score is expected for the intervention group.

The block design test examines the spatial visualization ability and motor skills of an individual. A decrease in time taken to complete the assessment is expected.

The symbol digit modality is a test for assessing cognitive impairment through speed and visual processing abilities of an individual. An increase in test scores are expected for the intervention group.

The Boston Naming Test presents individuals with a range of drawing of common objects and are asked to name them one at a time. This tests for dementia and cognitive decline. An increase in test scores and lower error rate is expected within the intervention group.

The colour trails test assesses sustained and dividend attention. A decrease in time taken to complete the assessment is expected.

Changes in brain structure including grey and white matter will be assessed using magnetic resonance imaging. A reduction or absence of change in grey and white matter atrophy is expected in the intervention group.

Magnetic resonance imaging will be used to determine hippocampal volume. A reduction or absence of change in hippocampal atrophy is expected in the intervention group.

A range of blood (allantoin, protein carbonylation, hercynine) and urinary biomarkers (F2-isoprostanes, 8OHdG, 8OHG) of oxidative damage will be measured at various timepoints throughout the study, utilizing liquid chromatography mass spectrometry. A reduction in these blood and urinary oxidative damage products is expected in the intervention group.

Over the course of the study a reduction in inflammatory cytokines (C-reactive protein, tumor necrosis factor alpha, interleukin-1 etc.) is expected in the intervention group, as determined through enzyme-linked immunosorbent assay

The geriatric depression scale is a self-reported assessment to identify depression in elderly individuals, through a series of questions. Scores are based on the sum of the answers indicating depressive symptoms are tallied and give an indication of the likelihood of depression. At the conclusion of the study a reduction or absence of change is expected in the geriatric depression scale.

The geriatric anxiety inventory is a self-reported assessment to identify anxiety syndromes in elderly individuals, through a series of questions. At the conclusion of the study a reduction or absence of change is expected in the geriatric anxiety score.

National University Hospital, Singapore

National University, Singapore

National University Health System, Singapore

Randomized, double-blinded, placebo-controlled study

Investigational compound and placebo coded by manufacturer. Codes provided in envelope will only be unsealed at the end of the study (data assessment) or in case of emergency.

Patients with a positive lactose-breath test and complaints during the test

Patients with a positive lactose-breath test and no complaints during the test

Subjects with a negative lactose-breath test

Lactose Intolerance

TARGID, KU Leuven

Comparison of the Colonic Metabolism in Patients With Lactose Intolerance and Healthy Controls

Fecal water, prepared by ultracentrifugation of fecal samples, will be incubated with HT-29 cells, a colonic adenocarcinoma cell line. Fecal water genotoxicity will be assessed using the Comet Assay, a sensitive method to detect DNA damage at the level of the individual eukaryotic cell. During the Comet Assay, the cells undergo electrophoresis causing movement of the damaged DNA out of the nucleus. The amount of DNA damage will be determined by measuring the extent the DNA has moved out of the nucleus, using fluorescent microcropy and dedicated software.

Fecal water cytotoxicity will be measured using the WST-1 assay, a colorimetric test based on the conversion of the tetrazolium salt WST-1 by cellular mitochondrial dehydrogenases present in viable cells. The dilution of fecal water at which 50% of the cells survive will be determined. The higher the dilution, the more cytotoxic the sample is.

d galactose/inflammation

Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)

Investigating the Efficacy of Ergothioneine to Delay Cognitive Decline

Comparison of the Colonic Metabolism in Patients With Lactose Intolerance and Healthy Controls

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