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Using an online website also is more efficient and economical for dieters than going to meetings or programs at another location, the study reported. The current trend in weight-loss websites is toward free, advertiser-supported sites rather than paid subscriptions, the study reported. Websites that provide high-quality content, are user friendly and can generate multiple income streams through ad revenue, email newsletters, user databases and affiliate programs will be profitable and attract investors, the study said. If a company wants to sell the weight-loss website, certain key factors affect the price: its revenue model, whether the site features custom programming and its audience characteristics, including frequency and time spent on the site, the study said. To read about two local entrepreneurs launching online weight-loss and fitness businesses, see our related feature under the Special Reports category of SmallBusinessChicago. Now called SmallBusinessExecutive, the site provides the stories behind small businesses and also the lessons their owners have learned in an effort to inform, inspire and connect businesses and the public in Chicago and beyond. About UsSimple Organic Life is here to help spread knowledge about some little known facts about food and medicine in our culture. DisclaimerWe here at Simple Organic Life do not hold backgrounds in medicine and anything read on this website should be read with an open mind and taken with a grain of salt. Alzheimer's disease (AD) is characterized by early and region-specific declines in cerebral glucose metabolism.
Daily administration of AC-1202 was evaluated in 152 subjects diagnosed with mild to moderate AD in a US-based, 90-day, randomized, double-blind, placebo-controlled, parallel-group study.
AC-1202 significantly elevated a serum ketone body (I?-hydroxybutyrate) 2 hours after administration when compared to Placebo. AC-1202 rapidly elevated serum ketone bodies in AD patients and resulted in significant differences in ADAS-Cog scores compared to the Placebo. BackgroundAlzheimer's disease (AD) is a common, age-associated, progressive, neurodegenerative disease. MethodsParticipantsSubjects were screened for eligibility at one of 23 clinical sites based within the U.S. BlindingThe participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. Extent of ExposureOne hundred fifty-two subjects were randomized in this study (86 AC; 66 PL) and received at least one dose of investigation product.
Similarly, among both APOE4(-) and APOE4(+) subjects, mean and median cumulative doses administered in the Placebo group were greater than the cumulative doses administered in the AC-1202 group. The website’s reputation, content quality, operating costs and current profitability also factor in, according to the study. The company also provides editorial services and consulting to media outlets and other organizations, including content strategy, editorial management, reporting, writing, editing and research. Muscles that aren’t used often enough lose their tone too, and that includes the muscles in your neck and jaw.
The information provided on this website is not a substitution for professional medical care, treatment or advice. Ketone bodies are produced by the body during glucose deprivation and are metabolized by the brain. Risk of developing the most common form of AD (sporadic or late onset) is principally linked to age, and the carriage status of the epsilon 4 (E4) variant of the apolipoprotein E gene (APOE). Eligible subjects were outpatients with a diagnosis of dementia of the Alzheimer type of mild to moderate severity according to NINCDS-ADRDA and DSMIV criteria, with a MMSE score of between 14 and 24 (inclusive) at Screen.
The double-blinding was achieved through the production and use of a Placebo similar in taste and appearance to the investigational product AC-1202.Statistical MethodsAs defined by the protocol, an intention-to-treat (ITT) analysis was used as the primary analysis of efficacy. Two hundred fifty-three participants with a diagnosis of probable AD were screened between October, 2004 and March, 2006. Subjects were permitted to interrupt or reduce their doses of investigational product, with the permission of principal investigators, if necessitated by adverse events. The cumulative doses received in APOE4(-) subjects were less than that for APOE4(+) subjects in the each treatment group.
An oral ketogenic compound, AC-1202, was tested in subjects with probable AD to examine if ketosis could improve cognitive performance.
Primary cognitive end points were mean change from Baseline in the AD Assessment Scale-Cognitive subscale (ADAS-Cog), and global scores in the AD Cooperative Study a€“ Clinical Global Impression of Change (ADCS-CGIC).
Among participants who did not carry the APOE4 allele (E4(-)), a significant difference was found between AC-1202 and Placebo in mean change from Baseline in ADAS-Cog score on Day 45 and Day 90. APOE4 behaves in a dominant, dose-dependent manner; a single copy increases risk of developing AD approximately 3 fold, while two copies increases risk approximately 10 fold (for review of APOE see [1]). The ITT population was defined as all subjects who were randomized, administered at least one dose of investigational product, and completed at least one follow-up visit.
Placebo and AC-1202 groups were also comparable in terms of Baseline MMSE and ADAS-Cog scores.
Subjects in the Placebo group received higher cumulative doses and remained on-study for a longer period of time than did subjects receiving AC-1202.
Median cumulative doses in APOE4(-) subjects was 3780 grams for AC-1202 subjects and 4950 grams for Placebo subjects. AC-1202 was compared to Placebo in several population groups, including: intention-to-treat (ITT), per protocol, and dosage compliant groups.
Clinically, AD is characterized by progressive decline in memory and language, and pathologically by accumulation of senile plaques and neurofibrillar tangles.
A CT or MRI within 24 months prior to Screen had to show no signs of tumor, structural abnormality, or degenerative disease. The ITT population was defined in the protocol as all subjects who were administered at least one dose and completed at least one follow-up visit subsequent to Baseline.
Over the course of the study, the AC-1202 group received a median cumulative dose of 4515 grams over a period of 90 days (representing 83.9% of the total intended dose of 5190 grams stipulated by the protocol). For APOE4(+) subjects, median cumulative dose was 4740 grams for AC-1202 subjects and 4970 grams in Placebo subjects (Table 4).The average number of days on treatment among APOE4(-) subjects receiving AC-1202 was less than that observed among the other three cohorts. Results were also stratified by APOE4 carriage status (a predefined analysis based on the epsilon 4 (E4) variant of the apolipoprotein E gene).

ADAS-Cog, MMSE and ADCS-CGIC) was imputed using the last observation carried forward (LOCF) method.
One hundred and forty subjects met these criteria and comprise the ITT population, of whom 77 were in the AC-1202 group and 63 in the Placebo group (Figure 1).
The Placebo group received a median cumulative dose of 4965 grams over a period of 90 days (representing 95.
Median time on therapy for APOE4(-) subjects receiving AC-1202 was 88 days, whereas the median time on therapy for the other three cohorts ranged from 90 a€“ 91 days (Table 4).Outcomes and estimationsADAS-CogPrimary outcomes defined by the protocol were change from Baseline in ADAS-Cog at Day 90 and total CGIC scores at Day 90.
Early imaging studies revealed low cerebral metabolic rates of glucose use (CMRglu) in subjects with probable AD [2], and this is now recognized as a general feature of the disease [3]. Subjects and their caregivers provided written informed consent, which included an optional written provision for genotyping.
The primary end points established a priori were change from Baseline at Day 90 in ADAS-Cog and comparison of the global scores of ADCS-CGIC at Day 90.
Fifty-two subjects withdrew before Day 104; twenty-four were due to adverse events (AEs), with the majority in the AC-1202 group (Figure 1). Figure 2A illustrates changes in ADAS-Cog scores over time in AC-1202 and Placebo ITT groups relative to Baseline. Furthermore, a significant pharmacologic response was observed between serum I?-hydroxybutyrate levels and change in ADAS-Cog scores in E4(-) subjects at Day 90 (p = 0.008). The most commonly affected areas include the posterior cingulate, parietal, temporal and prefrontal regions [4]. One-hundred thirty-five subjects (n = 75 AC-1202 (AC); n = 60 Placebo (PL)) consented to genotyping for the APOE locus.
E4(+) and E4(-) participants were not significantly different in age, sex, Baseline ADAS-Cog, or Baseline MMSE (Table 3). Adverse events occurred more frequently in AC-1202 subjects, were primarily restricted to the gastrointestinal system, and were mainly mild to moderate in severity and transient in nature. These deficits can be detected in pre-symptomatic, at risk individuals, such as E4 carriers, as young adults. Pre-defined additional analyses included interactions between cognitive outcomes and APOE genotype, safety, tolerability and BHB concentration levels.
Since higher ADAS-Cog scores represent increased impairment, a negative score in change from Baseline represents an improvement in cognitive performance (note Y axis is reversed in Figure 2 to illustrate the inverse relationship between improvement and ADAS-Cog scores). Such changes have been detected in cognitively normal subjects well before there is widespread neuronal loss or predicted plaque deposition, suggesting that low CMRglu is an early event in the disease [5].The cause of the hypometabolism remains unclear and may be due to loss of neurons or dendritic fields.
These 124 subjects were used in the analysis of APOE4 effects.RecruitmentThis was a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial sponsored by Accera, Inc.
The chemical name is 1,2,3-propanetriol trioctanoate (also known as tricaprylin or trioctanoin). The ANCOVA model included independent factors for group assignment, genotype, and group assignment by genotype interactions. Amyloid beta (AI?) [6] and fragmentation of the ApoE4 protein [7] have both been implicated in dys-regulation of mitochondrial function. It was conducted between October 5, 2004 and June 29, 2006 at 23 centers located within the United States. In addition, several authors have proposed changes in insulin signaling as a potential contributor to the development of hypometabolism [8a€“12]. Correlations between the 2 hour serum BHB level on Day 90 and the change from Baseline ADAS-Cog total score was determined by Pearson correlation statistics.Summary statistical analyses were provided by SIRO Inc.
Regardless of its cause, therapies aimed at correcting cellular metabolism may prove beneficial to the AD patient [13].One such promising therapy is the induction of ketosis (for overview see [14]). NeoBee 895 is a common food ingredient, made using glycerin from vegetable oil and fatty acids from coconut or palm kernel oil.
This was an out-patient study, and recruitment and testing was performed in individual investigators' clinical sites.
All investigators in this trial were pre-qualified for study participation based on their academic training and specialty area of practice. However, under certain situations, such as extended fasting, the liver will produce ketone bodies for use by extrahepatic tissues, including the brain. Placebo was isocaloric to the active formulation, and consisted of a mixture of 51% gum acacia, 37% dextrose, 10% safflower oil and 2% syloid (prepared by The Chemins Company).
Broomfield, CO USA.Accera funded the study, designed the protocol, and either conducted or commissioned the data analysis and interpretation.
Three compounds are normally considered ketone bodies: I?-hydroxybutyrate (BHB), acetoacetate (ACA) and acetone. Investigational product was given as a powder packaged in 30 gram sachets containing either active (equivalent to 10 grams of AC-1202) or matching Placebo.The contents of the sachets were mixed in one 8 oz.
Ketone bodies are an efficient fuel for cells [15, 16].Levels of circulating ketone bodies can be raised by adherence to a low-carbohydrate, high-fat, ketogenic diet. Ketogenic diets have been used extensively for the reduction of seizure frequency in children with refractive epilepsy [17] and have gained interest in several other neurological conditions, including amyotrophic lateral sclerosis [18], traumatic brain injury [19] and ischemia [20] (for review see [14, 21, 22]). These instructions were later amended to recommend reconstitution with a meal replacement drink (Ensurea„?, Abbott Laboratories, Inc) to improve product tolerability.
In addition, several preclinical studies have suggested that induced ketosis may be beneficial in AD. For example, the toxic effects of the AI? peptide in cultured neurons were shown to be mitigated by incubating the cells with BHB [23].
On Day 8, the dose was increased to two 30 gram sachets daily (equivalent to 20 grams AC-1202), which was continued through Day 90.
Also, a ketogenic diet reduced total AI?40 and AI?42 in a transgenic mouse model of AD after 38 days of feeding [24].Alzheimer's disease patients frequently undergo changes in food preference toward sweet, carbohydrate-rich foods [25a€“27], which would make compliance to a ketogenic diet difficult.
Daily doses were administered during breakfast, except on clinic visit days when the participants were administered investigational product at the clinic and asked to eat breakfast prior to their scheduled visit.
Therefore, AC-1202, a form of medium chain triglycerides (MCTs), was developed to safely elevate serum ketone bodies even in the presence of carbohydrate in the diet. On Day 104, a washout visit was conducted two weeks following the last product administration.Apolipoprotein E GenotypeHigh molecular weight DNA was isolated from whole blood for determination of APOE genotype using standard techniques.
MCTs were chosen for this study due to their safety profile [28], and long historical use in lipid malabsorption disorders and ketogenic diets [29].

Due to the unique physical properties of AC-1202, it is metabolized differently from the more common long chain triglycerides (LCT) [30]. If sufficient amounts of AC-1202 are consumed, a mild state of ketosis can be induced without modification of the diet.
At Screening, subjects and caregiver provided written informed consent and were assessed for eligibility to enter the study. In a pilot study of mild to moderate AD patients, induction of ketosis by AC-1202 rapidly improved cognitive performance in subjects lacking the APOE4 allele [31].The primary aim of the present study was to assess whether daily dosing of AC-1202 in mild to moderate AD subjects would improve cognitive performance as measured by change from Baseline in the AD Assessment Scale-Cognitive subscale (ADAS-Cog), and global score in the AD Cooperative Study a€“ Clinical Global Impression of Change (ADCS-CGIC) after 90 days. Additional outcomes investigated included how cognitive scores were influenced by APOE4 genotype status, as our earlier acute dosing study suggested that AD patients who lacked an APOE4 allele may respond better to ketosis [31]. Participants who qualified for the study returned for a Baseline visit (within 4 weeks of the Screening visit).
Baseline assessments included: adverse events (since initiation of Screen), concomitant medications, vital signs, ADAS-Cog, ADCS-CGIC and MMSE.
Visit 3 occurred 45 days (A± 3 days) after the Baseline visit, and is referred to as Day 45.
Day 45 assessments included: adverse events, concomitant medications, vital signs, ADAS-Cog, ADCS-CGIC and MMSE. Visit 4 occurred 90 days (A± 3 days) after the Baseline visit and is referred to as Day 90. Day 90 assessments included: adverse events, concomitant medications, vital signs, ADAS-Cog, ADCS-CGIC and MMSE.
Visit 5 occurred 104 days (A± 3 days) after the Baseline visit, and is referred to as Day 104. Day 104 assessments included: adverse events, concomitant medications, vital signs, weight, physical examination, ECG, safety labs, ADAS-Cog, ADCS-CGIC, and MMSE. Day 104 assessments examined performance after a two week washout period.ObjectivesThe primary aim of the present study was to assess if daily dosing of AC-1202 in mild to moderate AD patients would improve scoring on ADAS-Cog and ADCS-CGIC over a period of 90 days.
A secondary outcome examined whether or not daily dosing of AC-1202 would improve scoring on MMSE. The ADAS-Cog subscale consists of 11 tasks measuring cognitive abilities in memory, language, orientation, and praxis. The test includes seven performance items and four clinician-rated items, with a total score ranging from 0 (no impairment) to 70 (severe impairment).
The memory items includes two performance items (word recall and word recognition), and one clinician rated item (remembering test instructions). In word recall, the subject is shown ten words on flash cards and then asked to recall the words in any order. The cards containing the 12 words read to the patient are then mixed with 12 new word containing cards, and all 24 cards shown to the subject.
The subject is then asked to distinguish the new words from the words that were read aloud. Language items include two performance items (naming objects and following commands) and three clinician rated items (spoken language ability, word finding difficulty, and comprehension of spoken language).
In naming objects, the subject is presented with real objects (such as pencil, wallet, or comb) and asked to name them. In the clinician rated language items, the clinician evaluates the subjects' overall ability to understand and communicate spoken language during the course of the test. The orientation item consists of one performance test, in which the subject is asked a series of questions related to where the subject physically is located and time and date. In ideational praxis, the subject is asked to perform a task, such as mailing a letter, and is scored on the ability to complete the task.
Lowering of the ADAS-Cog score is a measure of cognitive improvement.The MMSE is a simple test used primarily for screening for dementia. The MMSE test measures several cognitive areas including: orientation, word registration, calculation, word recall, language and visual construction. Orientation (10 points) is measured by a series of questions relating to time and place (What is the year? Word registration (3 points) is measured by reading the subject three words and then the subject is asked to repeat them.
Attention and calculation (5 points) is measured by asking the subject to count backward from 100 by 7 s. Word recall (3 points) is measured by asking the subject to recall the 3 words from the word registration test. Language (8 points) is measured by asking the subject questions requiring the patient to name objects such as pencil or a wallet. Visual construction (1 point) is measured by having the subject draw a specific geometric shape.
The MMSE is much less sensitive than the ADAS-Cog to change, yet is advantageous in that it can be easily administered.The ADCS-CGIC is used to assess a meaningful clinical change over time. The ADCS-CGIC focuses on clinicians' observations of change in the subject's cognitive, functional and behavioral performance from Baseline status. Unlike ADAS-Cog or MMSE, CGIC takes into account a subject's overall function in the cognitive, behavioral and functional activity domains.
Part I is the Baseline evaluation during which the clinician interviews the patient and the caregiver to establish a reference point for future ratings. Part II is the follow-up interview with the patient and caregiver, and is used to evaluate the overall status of the patient relative to the reference Baseline interview. Adverse events and any changes in concomitant medication administration were recorded at all clinic visits.Sample sizeThe targeted sample size of 100 (50 AC-1202 and 50 Placebo) was determined empirically.
Near the end of the study, new participants entering the study were assigned to either AC-1202 or Placebo by an un-blinded independent medical monitor in such a manner as to obtain approximately 50 subjects who completed the study within each group. This intentional allocation resulted in an imbalance in the final number of randomized participants in each of the study groups; 86 randomized to AC-1202 and 66 randomized to Placebo (Figure 1).

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