Low carbohydrate trials

[Burylancs]

Note: This side discussion was split from a thread about a low carb app here - https://forum.diabetes.org.uk/boards/threads/new-low-carp-app-launched-by-freshwell-gp-surgery-free-to-download.96444/

Yesterday Freshwell GP surgery in the UK launched a wonderful Low Carb app.

Not for profit. Free to download. No ads, pop ups or premium membership. It should be available globally in the next day or so.

What an excellent resource especially for those new to low carb. Very well thought out. Extremely user friendly. Clear. Concise. 6 weekly educational modules should you want to go down that path. Lots of really helpful visuals. Sugar infographs. Ideas for food swaps. Meal planners. A progress section so weight, BMI, waist circumference can be tracked should you wish to. And so much more.

Here is the link. I feel it would be a great starting point for any newbies, moderators do you think it would be a good idea to pin this link Perhaps,?

https://lowcarbfreshwell.co.uk/app-2/

Interesting. I looked at the evidence section, it says how important RCTs are and then fails to produce a single RCT in evidence obviously there aren't any RCTs on diet, because it isn't possible to run one - the participants would know very well what they were eating. And credible tests on Low Carb diets dont exist because Low Carb is associated with kidney problems and thyroid problems and adrenal fatigue and so it would be unethical to stage one. The only evidence they produce is feeble anecdotal evidence from Dr. Unwin. Is this really the product of a reputable Surgery ? That is difficult to believe.

 

[everydayupsanddowns]

it says how important RCTs are and then fails to produce a single RCT in evidence obviously there aren't any RCTs on diet, because it isn't possible to run one

I think that’s possibly a bit harsh? There appear to be a number of randomised trials of various designs published in the literature which demonstrate the effectiveness of low carbohydrates for people with T2 diabetes.

eg https://www.nature.com/articles/s41387-017-0006-9
or https://pubmed.ncbi.nlm.nih.gov/15148063/

(those weren’t carefully selected, just the first two I followed links for a search of ‘low carb diet rct’

My understanding of the wider picture is that the picture is complex and mixed, and that some studies demonstrate superiority of other approaches eg low calorie. Some studies demonstrate people found low carb harder to stick to… while others demonstrate it was easier to stick to, or that there was no difference in whether people could maintain the diet.

Doubtless there are different meta-analyses, which draw different conclusions from the literature too.

Over the years I have seen resistance to lower carb approaches for T2 from healthcare professionals reduce, and there now seems to be an understanding that while they are not a ‘one size fits all‘ solution - they do work well for some individuals, and should be included among a range of options.

Diabetes UK published this position statement earlier this year

Low-carb diets position statement for professionals (May 2021)

This article is for professionals. If you would like to read information on low-carb diets for people with diabetes, you can find this on our low-carb diet and meal plan page. Here at Diabetes UK, we have put together this position statement to explain how low carb diets might be used to help...

www.diabetes.org.uk

 

[Burylancs]

I think that’s possibly a bit harsh? There appear to be a number of randomised trials of various designs published in the literature which demonstrate the effectiveness of low carbohydrates for people with T2 diabetes.

eg https://www.nature.com/articles/s41387-017-0006-9
or [M]

(those weren’t carefully selected, just the first two I followed links for a search of ‘low carb diet rct’

My understanding of the wider picture is that the picture is complex and mixed, and that some studies demonstrate superiority of other approaches eg low calorie. Some studies demonstrate people found low carb harder to stick to… while others demonstrate it was easier to stick to, or that there was no difference in whether people could maintain the diet.

Doubtless there are different meta-analyses, which draw different conclusions from the literature too.

Over the years I have seen resistance to lower carb approaches for T2 from healthcare professionals reduce, and there now seems to be an understanding that while they are not a ‘one size fits all‘ solution - they do work well for some individuals, and should be included among a range of options.

Diabetes UK published this position statement earlier this year

Low-carb diets position statement for professionals (May 2021)

This article is for professionals. If you would like to read information on low-carb diets for people with diabetes, you can find this on our low-carb diet and meal plan page. Here at Diabetes UK, we have put together this position statement to explain how low carb diets might be used to help...

www.diabetes.org.uk

Who wrote that position paper ? And what was their motive ?
Neither of the two examples you give look like RCTs and the first doesn't even claim to be, they look like Open Label tests like Taylor's DiRECT, he couldn't do an RCT either because everybody knew what they were eating/doing. So his evidence is not 'Gold standard' either.

 

[everydayupsanddowns]

Neither of the two examples you give look like RCTs and the first doesn't even claim to be,

I was happy to accept the authors descriptions in peer reviewed journals?

The title of the first:

Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes​

Title of the second:

A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial​

I don’t follow a low carbohydrate diet myself, and as I said I there is some heterogeneity in trial outcomes, which is quite possibly why confusion and differences of opinion continue.

Not least perhaps because individuals react differently to foods, and have different aspirations, tastes and needs.

I believe it is important that the forum supports those who feel that moderate and lower carbohydrate diets are an approach which has been shown to be effective in clinical trials and studies for some people, and are not inherently dangerous when undertaken with the support of a person’s GP or nurse.

 

[Burylancs]

The title of the first:

Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes​

As you see it isn't claiming to be an RCT. Randomly assigning individuals to one diet or another doesn't make it an Random Controlled Test which is a very different kettle of fish where nobody knows who is doing what not even
the researchers.

 

[everydayupsanddowns]

As you see it isn't claiming to be an RCT. Randomly assigning individuals to one diet or another doesn't make it an Random Controlled Test which is a very different kettle of fish where nobody knows who is doing what not even
the researchers.

Are you referring to double blind RCTs?

 

[DaveB]

Note: This side discussion was split from a thread about a low carb app here - https://forum.diabetes.org.uk/boards/threads/new-low-carp-app-launched-by-freshwell-gp-surgery-free-to-download.96444/



Interesting. I looked at the evidence section, it says how important RCTs are and then fails to produce a single RCT in evidence obviously there aren't any RCTs on diet, because it isn't possible to run one - the participants would know very well what they were eating. And credible tests on Low Carb diets dont exist because Low Carb is associated with kidney problems and thyroid problems and adrenal fatigue and so it would be unethical to stage one. The only evidence they produce is feeble anecdotal evidence from Dr. Unwin. Is this really the product of a reputable Surgery ? That is difficult to believe.

Do you have any evidence that shows low-carb diets cause kidney or any other problems? A non low-carb diet will often cause many health issues that can be proven.

 

[mikeyB]

It's perfectly possible for the people who gather the data to be kept unaware of which patients were on low carb diet to maintain the level of 'blinding' needed in such a trial. Whether that was the case is the important question, which should be contained within those reports.

 

[Burylancs]

Note: This side discussion was split from a thread about a low carb app here - https://forum.diabetes.org.uk/boards/threads/new-low-carp-app-launched-by-freshwell-gp-surgery-free-to-download.96444/



Interesting. I looked at the evidence section, it says how important RCTs are and then fails to produce a single RCT in evidence obviously there aren't any RCTs on diet, because it isn't possible to run one - the participants would know very well what they were eating. And credible tests on Low Carb diets dont exist because Low Carb is associated with kidney problems and thyroid problems and adrenal fatigue and so it would be unethical to stage one. The only evidence they produce is feeble anecdotal evidence from Dr. Unwin. Is this really the product of a reputable Surgery ? That is difficult to believe.

Oops ! This thread has nowt to do with me. A post has been taken out of context from where it belongs.

 

[Deleted member 21371]

Do you have any evidence that shows low-carb diets cause kidney or any other problems? A non low-carb diet will often cause many health issues that can be proven.

As it says on the website,

"CAUTION:​

If you suffer with any significant health conditions, particularly affecting the kidneys or liver or suffer with diabetes or high blood pressure – then please speak to a doctor or nurse before embarking on a low carb lifestyle..........."

Clearly the doctors running the site seem to think medical confirmation from your GP should be sought.

Also, they specifically have a requirement of a BMI over 25 before they offer it to their patients themselves, so it's a weight loss diet it seems not a lifestyle change.

"The Colne Valley PCN Low Carb Programme is now available to patients of Colne Valley PCN with a BMI of over 25, who are looking to lose weight, eat more healthily or potentially put their Type 2 Diabetes into remission."

 

[AndBreathe]

I wonder if any of these links might help at all, @Burylancs ?

Randomised Controlled Trials (RCTs) – Public Health Collaboration

phcuk.org

Randomised Controlled Trials (T2D) – Public Health Collaboration

phcuk.org

Insights from a general practice service evaluation supporting a lower carbohydrate diet in patients with type 2 diabetes mellitus and prediabetes: a secondary analysis of routine clinic data including HbA1c, weight and prescribing over 6 years

Background In a single general practice (GP) surgery in England, there was an eightfold increase in the prevalence of type 2 diabetes (T2D) in three decades with 57 cases and 472 cases recorded in 1987 and 2018, respectively. This mirrors the growing burden of T2D on the health of populations...

nutrition.bmj.com

 

[Burylancs]

I wonder if any of these links might help at all, @Burylancs ?

Randomised Controlled Trials (RCTs) – Public Health Collaboration

phcuk.org

Randomised Controlled Trials (T2D) – Public Health Collaboration

phcuk.org

Insights from a general practice service evaluation supporting a lower carbohydrate diet in patients with type 2 diabetes mellitus and prediabetes: a secondary analysis of routine clinic data including HbA1c, weight and prescribing over 6 years

Background In a single general practice (GP) surgery in England, there was an eightfold increase in the prevalence of type 2 diabetes (T2D) in three decades with 57 cases and 472 cases recorded in 1987 and 2018, respectively. This mirrors the growing burden of T2D on the health of populations...

nutrition.bmj.com

Not really. It's largely the same story as the Freshwell page. They tell us how important RCTs are, the Gold Standard, and then produce a list of just randomised trials instead of RCTs. And have you noticed how under powered those studies are - just some weeks in most cases.

 

[Deleted member 21371]

Not really. It's largely the same story as the Freshwell page. They tell us how important RCTs are, the Gold Standard, and then produce a list of just randomised trials instead of RCTs. And have you noticed how under powered those studies are - just some weeks in most cases.

I'm puzzled why they have a different site to the actual NHS site for the surgeries as well?
It seems to be very "dumbed down" and seems to claim it can cure anything that ails you?
Even though they actually claim there is no proof at all?

HEART DISEASE PREVENTION:​

It is well known that losing weight can reduce your risk of heart disease and stroke. It can also improve your blood pressure control and cholesterol levels. You may be able to reduce the amount of medication you take.

MENTAL HEALTH:​

Whilst there may be a lack of large trial data, people living a low carb lifestyle commonly report experiencing increased mental alertness, no longer feeling tired all the time and having much more energy and improved mood. People have also reported improved depression and anxiety symptoms.

MUSCULOSKELETAL:​

Many people are also reported as experiencing improved long term (chronic) pain (e.g. arthritis, fibromyalgia). Again, the large trial data is currently lacking, but there have been a large number of anecdotal cases.

GASTROINTESTINAL:​

Improved symptoms of Irritable Bowel Syndrome have been reported. It is well established that Non Alcoholic Fatty Liver Disease can also be reversed with weight loss.

NEUROLOGICAL:​

There have been many reports of improved migraine symptoms with a low carb diet.

CANCER:​

It is well known that obesity is linked with cancer, catching up with smoking as a major risk factor.

OTHER INFLAMMATORY DISORDERS:​

Many people adopting a low carb lifestyle have noted significant improvement with symptoms of inflammatory diseases such as asthma and eczema. Again, large trial data is lacking.

 

[Eddy Edson]

Anyway, I nthink this 2018 review from the great Kevin Hall still stands as an excellent overall summary: https://pubmed.ncbi.nlm.nih.gov/29677013/

Abstract​

Purpose of review: Summarize the physiological effects of low-carbohydrate diets as they relate to weight loss, glycemic control, and metabolic health.
Recent findings: Low-carbohydrate diets are at least as effective for weight loss as other diets, but claims about increased energy expenditure and preferential loss of body fat are unsubstantiated. Glycemic control and hyperinsulinemia are improved by low-carbohydrate diets, but insulin sensitivity and glucose-stimulated insulin secretion may be impaired, especially in the absence of weight loss. Fasting lipid parameters are generally improved, but such improvements may depend on the quality of dietary fat and the carbohydrates they replaced. Postprandial hyperlipemia is a potential concern given the high fat content typical of low-carbohydrate diets.
Summary: Low-carbohydrate diets have several potential benefits for treatment of obesity and type 2 diabetes, but more research is required to better understand their long-term consequences as well as the variable effects on the endocrine control of glucose, lipids, and metabolism.

Since then, RCT's conducted in the metabolic ward of the NIH facility where he works have fairly conclusively dealt with this part: claims about increased energy expenditure and preferential loss of body fat are unsubstantiated. These RCT's have pretty much put a fork in the "carbohydrate insulin model", the main buttress for the low-carb claims that carbs are worse than other macro's for weight, energy etc etc.