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Spinal Cord Stimulators for Chronic Back Pain Win FDA Approval

  Spinal Cord Stimulators for Chronic Back Pain Win FDA Approval On May 16, 2023, the U.S. Food and Drug Administration (FDA) approved spinal cord stimulation (SCS) devices from the pharmaceutical company Abbott to treat chronic  back pain  in people who have not had or are not eligible to receive back surgery, per a  press release from Abbott . Approval was granted after a six-month study of 200 participants showed that spinal cord stimulation provided significant relief and improvements in pain, function, quality of life, and mental health.Those enrolled in the trial had experienced an average of nearly 13 years of disabling chronic back pain. Participants were not eligible for corrective back operations because they were either medically frail or they had numerous degenerative changes in their spine, none of which were severe enough to qualify for corrective surgery but are nonetheless causing significant symptoms. After half a year, 85 percent of those implanted with Abbott’s SCS d

What Is the Golo Diet? A Complete Scientific Guide

 he Golo diet, also known as the Golo Metabolic Plan, was launched in 2009. According to the diet's official website, it was developed by a “team of dedicated doctors and pharmacists,” but it’s unclear exactly who they are. To follow Golo, the website notes, you eat “1,300 to 1,500 nutritionally dense calories” per day, and take a dietary supplement called Release. The goal, according to the website, is to “get healthier without cutting excessive calories, giving up food groups, or eating unhealthy diet foods.”

The plan hinges on the idea of regaining control of your metabolic health, including making your metabolism “more efficient,” addressing insulin resistance (insulin is a hormone that regulates the amount of glucose in the blood, and insulin resistance is a hallmark of prediabetes and type 2 diabetes), and balancing hormones (such as hunger and stress hormones). The first element, insulin resistance, appears to be the most important target of the program. The company states on its website that the dietary supplement stops weight gain and is able to “reverse insulin resistance” so your body can “release stored fat.” But it’s likely not necessary to take a supplement in order to improve insulin sensitivity. According to the Centers for Disease Control and Prevention (CDC), reversing insulin resistance involves increasing physical activity, losing weight, avoiding high blood sugars, managing stress, and sleeping adequately.

Golo makes some really big medical claims, including that its customers have reported fewer symptoms of PCOS (polycystic ovary syndrome), have been cured of prediabetes or type 2 diabetes, and have lowered their blood pressure and cholesterol.

Pros of the Golo Diet

The good news is that you are encouraged to eat good-for-you foods. “The plan appears to be a whole-foods, healthy-eating plan that prioritizes fruits, vegetables, lean protein, nuts, and whole grains over refined grains,” says Samantha Cassetty, RD, of New York City. “This would be a very healthy plan to promote a healthier weight and positive health outcomes,” she says. 

With a focus on whole foods, there’s less of a reliance on processed foods, and that on its own can be a boon to your health. Cassetty points to a study published May 16, 2019, in Cell Metabolism that suggests this way of eating may be favorable to weight loss. The study was small (consisting of only 20 adults), but for two weeks participants ate either an ultra-processed or unprocessed diet. Then they switched diets for another two weeks. When eating processed fare, participants consumed 500 more calories (from carbs and fat) than the fresh-food dieters, and gained about two pounds. As for those on the diet with fresh food? They lost two pounds. “People who eat processed foods don’t fill up as quickly and eat faster, so they consume more food,” says Cassetty.

Cons of the Golo Diet

This diet hinges on the supplement, called Release. According to the company’s FAQ, Release is made of seven natural plant-based ingredients and three minerals:

  • Zinc
  • Magnesium
  • Chromium
  • Banaba leaf extract
  • Rhodiola rosea
  • Berberine extract
  • Salacia extract
  • Gardenia extract
  • Inositol
  • Apple extract

It is touted as a weight loss supplement that prevents insulin levels from rising. Limited evidence shows that Banaba leaf extract may be used to lower blood glucose levels in people with diabetes. Rhodiola rosea is a flowering plant that may impact cells that store fat, particularly in the midsection, per a study.

Still, this preliminary research is not solid evidence that this type of supplement — or any weight loss supplement — is a silver bullet. “There has never been a supplement to materially and meaningfully boost your weight loss for any sustainable or long-term period,” says Cassetty.

What’s more, there are potential safety issues with the Release supplement. “I’m a bit concerned with the supplement,” says Emmaline Rasmussen, RDN, the owner of Sound Nutrition in Chicago. She suggests that anyone interested consult a physician and registered dietitian before trying the Golo diet, especially those who are managing diabetes. “Diabetes may be regulated with medication, and it can be potentially dangerous to start a diet that claims to impact insulin levels without medical supervision,” she says.

While the company claims the supplement is safe to take with medications, at the very least you’ll want to ask your healthcare team if your meds should be adjusted. (The company notes that Release may lower blood sugar, so certain medications may need to be adjusted.) You may also be taking medication for high blood pressure, a condition that this diet claims to improve. In that case, your doctor should keep tabs on any progress and assess if your prescription needs to be adjusted in any way.

Also, keep in mind that in general, the U.S. Food and Drug Administration (FDA) doesn’t regulate supplements the way they do conventional medications. Namely, the FDA does not test supplements before they’re marketed — that responsibility falls to the supplement makers.

Scientific Research on the Golo Diet

There is a lack of peer-reviewed published research in a medical journal on the Golo diet. One of their pilot studies did not have a placebo group. (Including a placebo group is part of the gold-standard in research, as it can help scientists assess if the results were attributable to the intervention.) Peer review is critical, too, says Cassetty: “If research does not go through that rigor, the results are not as meaningful,” she says.

A small randomized, double-blind, placebo-controlled study on Golo appeared in the peer-reviewed journal Trends in Diabetes and Metabolism in May 2019 and is linked on the company’s website. Consisting of 68 participants, those who followed the Golo diet and took Release lost about 13 pounds over 13 weeks, compared with the placebo group that lost about 7.5 pounds. For perspective, however, keep in mind that the study was small and 13 weeks is short-term results — it’s not clear what happened to these participants after three months. (Essentially, it’s easy to lose weight on any diet if you follow it for that short of a time period.) Note, though, that this study was funded by the Golo company, so there is a possible conflict of interest.

Golo Diet Reviews

It’s entirely possible you will lose weight on the Golo diet. But experts including Rasmussen attribute that to the calorie restriction rather than the Release supplement. “When reducing calories, most people will lose weight,” she says. 

It’s easy to find a number of rave reviews on their website, with people displaying their “before” and “after” bodies. “This promotes an idea that there’s one look to health, but bodies come in a lot of different sizes, and healthy does not have a look,” Cassetty says.

ricing for the Golo Diet

To start the diet, you will order the Release supplement. Along with the supplement, you will receive the Golo for Life plan (a guidebook) and myGolo (meal plans, coach support, recipes), and the Defeating Diet Obstacles guide, a total package the company says is valued at $279.

How much Release you purchase appears to be tied to how much weight you’d like to lose. 

This is what’s currently llisted on their website:

  • 1 bottle of Release, to lose 10–20 pounds (lb): $59.95
  • 2 bottles of Release, to lose 21–40 lb: $99.90
  • 3 bottles of Release, to lose 41–60 lb: $119.85
  • Golo Diet Food List

    Here’s a sample list of foods that you can eat and the types you should avoid on the Golo diet.

    What to Eat 

    According to the website, foods that are encouraged are:

    • Butter
    • Eggs
    • Whole milk
    • Cheese
    • Greek yogurt
    • Fruits
    • Vegetables
    • Grains, including bread and pasta 
    • Chicken
    • Fish
    • Steak
    • Nuts

    What to Avoid

    There are few restrictions beyond focusing on nutrient-dense whole foods. People are also encouraged to avoid highly processed products like diet shakes, bars, and meal replacements and to limit or avoid heavily refined and processed foods and snacks in general.

    A 1-Day Sample Menu on the Golo Diet

    According to a private video on Golo’s YouTube channel, you should organize your meals in suggested serving ratios. 

    Breakfast 1 fat, 2 proteins, 2 carbohydrates, 1 vegetable

    Lunch 1 fat, 2 proteins, 1 carbohydrate, 2 vegetables

    Dinner 1 fat, 1 protein, 1 carbohydrate, 2 vegetables

    One overarching idea is to spend one to two hours per week on meal prep. You can then prepackage containers with foods in their correct ratios and grab and go throughout the week. Doing it this way means you’ll likely repeat meals and foods throughout the week. 

    Breakfast 2 hard-boiled eggs, overnight oats made with zucchini, chia seeds, and coconut flakes

    Lunch Chicken, salad greens, sweet potatoes, and coconut oil

    Snack Celery sticks

    Dinner Chicken, broccoli cooked in coconut oil, sweet potatoes

  • Resources We Love: Golo Diet

    Best Websites for Info on the Golo Diet 

    Golo for Life

    If you are interested in trying the Golo diet, this is the website you’ll be using frequently. Not only can you find information about the diet itself, additional resources like their blog, but you can also sign up to purchase the Golo for Life plan and supplements.

    National Center for Complementary and Integrative Health

    A key cornerstone of the Golo diet is their metabolic supplement, which contains various herbal ingredients. For more information about how the ingredients work and the scientific data (or lack thereof) behind them in terms of insulin function and weight loss, you can use the NCCIH’s various databases, as well as learn how to stay safe when using complementary medicine.

    Nutrition.gov

    When you’re starting out on your journey to lose weight for the first (or fifth time), it’s helpful to read through verified resources, which will give you the knowledge and support you need to be successful. Nutrition.gov cuts through the chatter of diet programs and provides additional resources on Selecting a Weight Loss Program, Choosing a Safe and Successful Weight-Loss Program, and What You Should Know About Popular Diets, as well as shopping lists, menus, how to eat healthy while dining out, and info about incorporating exercise into your plan. 

    Best Books

    Insulin Resistance Diet for Beginners

    Though this well-rated book is not specific to the Golo diet, it centers itself around the mission of the plan: Reversing insulin resistance. Written by the registered dietitian Marlee Coldwell, RD (now Marlee Hamilton), the book lays out a doable plan for managing blood sugar, shopping guidelines, and quick and easy meals (for example penne with sausage and kale, grilled peach and prosciutto pizzas) to make it all happen.

    One Last Thing About the Golo Diet

    The Golo diet is a calorie-restricted diet, which is likely why some people lose weight on it. The money you spend is for the Release supplement, a formula containing herbs and minerals designed to help you control your blood sugar and insulin. “This may be a drastic change that leaves you hungry all the time, which would not be a sustainable recipe for health and happiness,” says Cassetty.


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Spinal Cord Stimulators for Chronic Back Pain Win FDA Approval

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