Scientists are set to begin human trials on a 'fat pill' that could reduce the need for gastric bypass surgery and help solve the obesity crisis.
The capsule, packed with a mix of natural oils, is believed to trick the stomach into thinking it's full and suppress the appetite.
It has been laboratory-tested on human tissue for more than two years by a team of researchers at Queen Mary University of London (QMUL), in a project part-funded by the charity Bowel & Cancer Research.
The team has now won funding to test the capsule and its contents for real.
Forty volunteers will spend 18 months helping to establish the correct dosage levels and manage possible side-effects.
"This first phase will confirm whether the capsule does inhibit the appetite - and our research so far gives a very strong indication that it does. It will also give an assessment of blood hormone associated with appetite and glucose regulation," said lead researcher Ashley Blackshaw, Professor of Enteric Neuroscience at QMUL's Wingate Institute.
"Because the contents of the capsule are natural oils, the only side-effect we're expecting is possibly nausea if there's too high a dose."
The volunteers will be overweight, but not necessarily obese. "We need people who are on the spectrum of having a reduced response to gut hormones," said Professor Blackshaw.
If the first phase is successful, a second group will spend a further six months trialling what researchers have nicknamed 'the fat pill'. They will be obese, morbidly obese, or on the waiting list for a gastric bypass.
"All they have to do is swallow capsules before every meal when the body is ready to release lots of hormones, such as insulin," said Professor Blackshaw.
"What we have is a simple capsule containing a fairly cheap natural resource. The combination of oils is very specific and, we believe, will supercharge the appetite hormones in the gut. Not only are they natural nutrients, they are also three or four times more potent than one oil on its own.
"If the trials work, this could be a major weapon in tackling the obesity crisis and type II diabetes. It could also cut the need for gastric bypass surgery which costs the NHS millions every year."
The 'fat pill' works by sending special food supplements directly to the lower bowel, bypassing the small intestine. That causes the release of hormones which suppress the appetite and help with the release of insulin.
"It tricks the brain into thinking the stomach is full and stops even the hungriest person from eating," said Professor Blackshaw.
"It should have the same effect as gastric bypass surgery. The difference is that surgery is expensive, invasive and irreversible.
"The 'fat pill' is just like swallowing a fish oil capsule. It's a totally novel idea, and we're very excited to be proceeding to human trial. We are hopeful that the treatment will be widely available in the next five years.
"The difference between lean people and obese ones is that obese people ignore the signals from the small intestine that tell the brain that the body is full.
"We believe it's possible to trick the digestive system into behaving as if a bypass has taken place by administering specific food supplements which bypass the small intestine and release strong stimuli in the same area of the lower bowel where that sense of feeling full occurs.
"We are pursuing the opportunity to intervene directly with fatty acid, amino acid and protein sensing pathways of the lower bowel to modify endocrine responses."
Professor Blackshaw and his collaborator Dr Madusha Peiris are based at the Wingate Institute for Neurogastroenterology, part of Barts and the London School of Medicine and Dentistry, Queen Mary University of London. The human trials are being funded through the charity Bowel & Cancer Research with the support of the Moulton Foundation.
"We're extremely grateful to Bowel & Cancer Research and to Jon Moulton's Charitable Foundation for supporting this project. This work wouldn't be happening without this charitable support. Money for research doesn't grow on trees at the best of times, and because we're dealing with natural nutrients as opposed to drugs, securing funding for this whole project was particularly challenging," he said.
Bypass surgery is the most effective current treatment for obesity and type II diabetes. There are rapid benefits in terms of weight loss and improvement in blood sugar levels. The National Institute of Health and Care Excellence (NICE) has produced guidelines suggesting its use could be expanded in the NHS to tackle an epidemic of type 2 diabetes.
There has been a marked increase in obesity in the UK. In 1993, 15 per cent of the population were obese. In 2013, this rose to 25 per cent. In England in 2013, 56.4% of women aged 34-44 and 62% of women aged 45-54 were classified as overweight or obese.
England's Chief Medical Officer Dame Sally Davies said in her annual report in 2015 that obesity is the biggest threat to women's health and the biggest threat to future generations. She said tackling obesity should be a 'national priority' to avert 'a growing health catastrophe'.
At the same time, weight-loss surgery has increased 30-fold in the last decade. More than 8,000 operations take place annually on the NHS, and many more through private clinics.
Also called bariatric surgery, it is used as a last resort to treat people who are dangerously overweight.
It is only available on the NHS to treat people when all other treatment, including lifestyle changes, have not worked. Privately the costs are £5,000-£8,000 for a gastric band, and up to £15,000 for gastric bypass surgery.
Deborah Gilbert, Chief Executive of Bowel & Cancer Research, said: "Being overweight, particularly carrying weight around the waist, is now recognised as a major risk factor for bowel cancer, as well as a number of other health conditions. We are delighted that we were able to help with securing the funding to enable this work to proceed. The impact on this increasing problem both at home and in many other developed countries could be immense. We wish Professor Blackshaw and his team the very best with it."