How can we prevent or delay Alzheimer’s?

How can we push back or prevent Alzheimer’s?” asks Claudette in Quebec City. As with most health-related issues, the answer is we can do our best with diet and exercise. The Globe’s dietitian wrote a piece this week that outlined a new diet that may help stave off Alzheimer’s:

According to a study, a hybrid of these two eating plans – called the MIND diet – is associated with a significantly lower risk of developing Alzheimer’s disease. That’s true even if you don’t follow the diet strictly.

Along with elements from the Mediterranean and DASH diets, the MIND diet includes specific foods and nutrients found in past studies to be linked to optimal brain health. The diet’s 10 “brain-healthy food groups” include green leafy vegetables, other vegetables, berries, nuts, beans, whole grains, fish, poultry, olive oil and wine.

The plan also advises that five unhealthy food groups – red meat, butter and stick margarine, cheese (because of its high saturated-fat content), pastries and sweets, and fried or fast food – be limited.

The findings also hinted that the longer a person follows the MIND diet, the greater the protection from Alzheimer’s disease.

While this observational study shows promise for reducing the risk of Alzheimer’s, it doesn’t prove cause and effect. The results need to be confirmed by randomized controlled trials, the gold-standard evidence for a cause-and-effect relationship.

These new findings add to a growing body of evidence that strongly suggests your overall dietary pattern matters more than single nutrients when it comes to Alzheimer’s prevention.

Eating a combination of healthful foods that deliver a wide range of protective nutrients while, at the same time, minimizing your intake of foods that may harm brain cells is what counts.

Read the entire article – including the specifics o the MIND diet – here.  In a December 2014 article, The Globe’s fitness expert Alex Hutchison wrote about U.S. research that studied 150,000 participants and showed, “regular exercise lowers the risk of dying from Alzheimer’s by as much as 40 per cent – an indication that the disease’s progression is not unchangeable.”

“Currently, doctors do not screen for Alzheimer’s disease susceptibility because of the belief that nothing can be done for those at risk,” says Dr. Paul Williams, a staff scientist at Lawrence Berkeley National Laboratory in California and the author of the study. “However, our results add to the growing body of scientific evidence suggesting that people can be proactive in lowering Alzheimer’s disease risk.”

The results also showed that running and walking are equally effective as long as you burn the same amount of energy overall. That means you need to spend about twice as much time (or cover 50 per cent more distance) walking briskly compared to running, Williams says.

That doesn’t mean that lesser amounts of exercise are useless, cautions Dr. Jordan Antflick of the Ontario Brain Institute, who co-ordinated a 2013 report on the role of exercise in Alzheimer’s prevention and treatment.

“You don’t have to run a marathon,” he says. “Even raking the leaves or going for a walk after dinner can help.”

After reviewing more than 800 studies and selecting the 45 highest-quality trials, Antflick and his colleagues concluded that more than one in seven cases of Alzheimer’s could be prevented if everyone simply met the minimum guidelines of 150 minutes of exercise per week, in doses as short as 10 minutes at a time. Given that approximately 10 per cent of Canadians over 65 have Alzheimer’s, that would save tens or even hundreds of millions of dollars in health-care costs.

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How much naturally-occurring sugar (i.e. from fruit or milk) is healthy to eat?

How much naturally-occurring sugar (i.e. from fruit or milk) is healthy to eat?

There are no guidelines to limit natural sugars in fresh fruits and vegetables and milk because there is simply no evidence that consuming these sugars is harmful to our health.

Earlier this year, the World Health Organization (WHO) released strict limits for added sugars – those that are added to foods during processing. WHO called for adults to cut their intake to less then 10 per cent of daily calories or, even better, less than 5 per cent. For a standard 2000-calorie diet, these limits translate to no more than 50 grams (10 per cent calories) and 25 grams (5 per cent calories).

These new guidelines are based on evidence reducing added sugar intake to less than 10 per cent of daily calories helps guards against overweight and obesity. The WHO defined added sugars as those “added during processing, at home, and sugars naturally present in honey, syrups, fruit juices and fruit juice concentrates”.

But unlike added sugars, there are no specific intake guidelines for natural sugars which occur in fresh fruit and vegetables (called fructose) and milk and yogurt (called lactose).

You might wonder why fruit juice, which contains naturally-occurring sugar (not added sugar) needs to be limited along with other added sugars.  While pure fruit juice does deliver vitamins and minerals, it can be high in natural sugar. One cup of orange juice has 23 grams of sugar while one medium orange has 12 grams. And fruit juice has none of the fibre whole fruit does, so it doesn’t fill you up.  The extra calories from sugar in fruit juice can, therefore, lead to unwanted weight gain if you drink it regularly to quench your thirst.

Current dietary guidelines recommend that total carbohydrates can make up 45 to 65 per cent of your total daily calories.  If you eat, say, 1800 calories per day that means you can consume 202 to 292 grams of carbohydrates each day.

The majority of your carb grams will come from naturally-occurring sugars in fruit and vegetables and starches in foods like whole grains, starchy vegetables and beans and lentils.

The smallest contributor to your total carbohydrate intake – less than 10 per cent of your daily calories – should be added sugars.

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There’s an apple that will never brown for sale in Canada. What health risks do GMO foods pose?

There’s an apple that will never brown for sale in Canada. What health risks do GMO foods pose?

The Arctic apple, engineered to be non-browning, became the latest genetically modified food to be approved by Health Canada this week. We’ll likely start seeing it in stores in 2017, according to Neal Carter, founder of Okanagan Specialty Fruits Inc., the British Columbia-based company that created the apple.

While there are a small number of scientific studies suggesting that these foods pose risks to human health and the environment, the overwhelming scientific consensus is that they are as safe as any other conventional food. Health Canada, the World Health Organization, the U.S. Academy of Sciences and the American Medical Association all endorse that view.

GMO crops have been part of our lives for more than two decades. The first such crop was approved by the U.S. Food and Drug Administration in 1994.

They have proliferated ever since. More than 120 genetically modified foods have been approved for sale in Canada. These range from insect resistant soy to virus resistant squash. (The complete list of “Novel Foods” approved by Health Canada can be found here.)

In explaining its approval of the Arctic apple, Health Canada provided this statement: “A gene was introduced into the Arctic apple that results in reduction in the levels of enzymes that make apples turn brown when sliced. In every other way, the Arctic apple tree and its fruits are identical to any other apple.”

The statement goes on to say that a thorough review was conducted by scientists with expertise in molecular biology, microbiology, toxicology, chemistry and nutrition.

“Following this assessment, it was determined that the changes made to the apple did not pose a greater risk to human health than apples currently available on the Canadian market,” it said. “In addition, Health Canada also concluded that the Arctic apple would have no impact on allergies, and that there are no differences in the nutritional value of the Arctic apple compared to other traditional apple varieties available for consumption.”

While there are a small number of studies that have suggested GMO foods do pose health risks, including linking GM corn to cancer in rats, or that DNA from GM crops can be transferred to humans who eat them, most of these studies have either been retracted, published in non-peer reviewed journals or questioned by independent scientists.

Meanwhile, there are more than 2, 000 studies that have concluded GMO foods pose no greater health risk than convention or organic foods.

“In order to maintain the position that GMOs are not adequately tested, or that they are harmful or risky, you have to either highly selectively cherry pick a few outliers of low scientific quality, or you have to simply deny the science,” Steven Novella, an assistant professor at the Yale University school of medicine, has written.

However, there is evidence to suggest that genes from GMO crops can migrate to non-GMO crops, as noted by the World Health Organization. (The WHO and other organizations refer to this as “outcrossing,” rather than the loaded term “contaminate.”) Separating GM crops from conventional crops is one way to address this problem.

Many people who oppose genetically modified food, including David Suzuki, argue that we still do not know their long term health effects. After all, these foods have only been part of our diet since 1994.

By its very nature, this is objection is difficult if not impossible to address without getting caught in an unproductive line of reasoning: Thousands of studies say these foods don’t pose a health risk, but on a long enough timeline they just might. Okay, but thousands of studies say they’re fine.

One way out of this is to label GMO foods. That way, supporters of labelling argue, those who are skeptical or simply don’t wish to consume GMOs would be able to exercise choice at the grocery store. Suzuki has called this a “basic right to choice.”

More than 60 countries currently require such labelling – and Canada is not one of them. Why? The government has said it does not mandate labelling because there are no known health risks to eating GM foods.

Do consumers nevertheless deserve labels in order to make informed decisions? That is a whole other question.

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What’s the current recommendation about eggs? How many should I eat per day?

What’s the current recommendation about eggs? How many should I eat per day?

A 2013 report, published online in the American Journal of Clinical Nutrition, concluded that eating an egg a day – yolk included – did not increase the risk of cardiovascular disease in healthy people.The bad news: Egg eaters were more likely to develop type 2 diabetes. And among people who already had diabetes, an egg-a-day habit substantially upped the likelihood of a heart attack or stroke. That said: Cholesterol is essential for life. It’s needed to build cell membranes, form healthy nerve fibers and make vitamin D and hormones such as estrogen and testosterone.Although high blood cholesterol is an established risk factor for a heart attack and stroke, the link between cholesterol in foods and cardiovascular disease remains unclear. Most studies have found that dietary cholesterol has little, if any, impact on blood-cholesterol levels.

While eggs may have little effect on your fasting blood-cholesterol level, that may not be the case for your “after-meal”, or postprandial, blood cholesterol. (Fasting blood cholesterol is measured after consuming no food or drinks, with the exception of water, for nine to 12 hours.)

There is mounting evidence that, depending on what you eat, postprandial blood fats can damage blood vessels and promote atherosclerosis (hardening and narrowing of the arteries). Small studies have shown that eating a cholesterol-rich meal can enhance the blood-cholesterol-raising effects of saturated (animal) fat and increase the chance that your LDL (bad) blood cholesterol becomes oxidized.So what are we to make of all this? Are eggs off the menu? Most people don’t have to worry about eating an egg yolk to two each day; the evidence that the amount of cholesterol you eat raises LDL blood cholesterol is weak.

So weak, in fact, that scientific advisory panel for the 2015 iteration of the Dietary Guidelines for Americans is recommending the decades-long recommendation to avoid eating foods high in cholesterol be dropped.Some people, though, are sensitive to the blood cholesterol-raising effect of food cholesterol. People with diabetes and those with heart disease should limit their intake of egg yolks to four per week (some experts advise avoidance).

Instead of eating a two-egg omelette with 266 milligrams of cholesterol, have a cholesterol-free white-only omelette for a good source of protein, riboflavin (a B vitamin) and selenium. Try a cholesterol-free egg product sold in the egg case at grocery stores.Keep in mind that there are variables we do not yet know. It’s possible that consuming antioxidant-rich foods (e.g. berries, citrus fruit, red peppers, spinach, green tea) or anti-inflammatory foods (e.g. salmon, chia seeds, ground flax, walnuts) with an egg could mitigate the harmful postprandial blood fat effects.

But most of all, let’s not forget that preventing cardiovascular disease is about a whole lot more that cutting back on egg yolks. Limiting refined (white) starchy foods and added sugars, reducing trans fats, emphasizing monounsaturated fats (e.g. olive oil, avocado, almonds), increasing omega-3 fats from fish oil, limiting sodium intake, getting regular exercise and maintaining a healthy weight are key strategies to guard against heart disease and stroke.

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Good Clinical Practice GCP

Good clinical practice (GCP)

is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, that is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines

GCP follows the International Conference on Harmonisation (ICH) of GCP guidelines. GCP enforces tight guidelines on ethical aspects of a clinical study. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. Ongoing research shows that whether conducting research involving a new drug, a behavioral intervention, or an interview or survey, GCP provides investigators and their study teams with the tools to protect human subjects and collect quality data.

GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.

GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.

Good Clinical Practice Overview

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THE TUSKEGEE EXPERIMENT

CLINICAL RESEARCH ETHICS: THE TUSKEGEE EXPERIMENT

The Tuskegee syphilis experiment (/tʌsˈkiːɡiː/) was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African-American men in Alabama. They were told that they were receiving free health care from the U.S. government

The Public Health Service started working on this study in 1932 during the Great Depression, in collaboration with the Tuskegee Institute, a historically black college in Alabama. Investigators enrolled in the study a total of 600 impoverished sharecroppers from Macon County, Alabama. Of these men, 399 had previously contracted syphilis before the study began, and 201 did not have the disease. The men were given free medical care, meals, and free burial insurance for participating in the study. None of the men infected was ever told he had the disease, nor was any treated for it with penicillin after this antibiotic became proven for treatment. According to the Centers for Disease Control, the men were told they were being treated for “bad blood”, a local term for various illnesses that include syphilis, anemia, and fatigue.

The 40-year study was controversial for reasons related to ethical standards, primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease they were studying. Revelation in 1972 of study failures by a whistleblower led to major changes in U.S. law and regulation on the protection of participants in clinical studies. Now studies require informed consent  communication of diagnosis, and accurate reporting of test results.

By 1947, penicillin had become the standard treatment for syphilis. Choices available to the doctors involved in the study might have included treating all syphilitic subjects and closing the study, or splitting off a control group for testing with penicillin. Instead, the Tuskegee scientists continued the study without treating any participants; they withheld penicillin and information about it from the patients. In addition, scientists prevented participants from accessing syphilis treatment programs available to other residents in the area. The study continued, under numerous US Public Health Service supervisors, until 1972, when a leak to the press resulted in its termination on November 16 of that year. The victims of the study included numerous men who died of syphilis, 40 wives who contracted the disease, and 19 children born with congenital syphilis.

The Tuskegee Syphilis Study, cited as “arguably the most infamous biomedical research study in U.S. history”,led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections (OHRP) It also led to federal laws and regulations requiring Institutional Review Boards for the protection of human subjects in studies involving human subjects. The Office for Human Research Protections (OHRP) manages this responsibility within the USDepartment of Health and Human Services (HHS)

Dr. Nicholas Herten-Greaven lectures about the Tuskegee syphilis experiment as part of the Ethics in Clinical Research course at Oxford College

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