Cardiometabolic Risk Clinical Trial
Official title:
CALIBER (Carbohydrates, Lipids and Biomarkers of Traditional and Emerging Cardiometabolic Risk Factors) Phase 1: A Pilot Study in Normal-weight and Overweight Adults.
Pilot study to compare the impact of following a low-carbohydrate, high-fat diet versus following a high-carbohydrates, moderate-fat diet (UK dietary guidelines) on cardiometabolic risk markers and associated behaviours in a normal-weight and overweight adult population.
Cardiometabolic diseases (CMD), such as type 2 diabetes and cardiovascular disease (CVD), are
globally amongst the highest contributors to morbidity and mortality with high (cost)
implications to the overall economy and health care systems. A number of risk markers have
been associated with CMDs, including blood serum markers, low levels of lean mass and high
levels of body fat, including increased waist circumference. Dietary factors and nutritional
status have long been linked with specific markers of cardiometabolic (CM) risk. The quantity
and quality of dietary carbohydrates has been associated with increased serum triglycerides
levels, increased body fat mass, increased waist circumference and visceral fat around the
organs in particular. They also seem to increase food cravings. Whilst official dietary
guidelines in the UK and elsewhere still recommend a high carbohydrate and low fat diet as
standard, these recommendations have increasingly been challenged. Evidence has been mounting
that very-low carbohydrate (ketogenic) and low carbohydrate diets can ameliorate CM risk
factors, especially when a personalised rather than a one-size-fits-all approach is being
taken. Response to carbohydrate load and adherence to dietary interventions can vary widely
dependent on individual substrate and energy metabolism and insulin-resistant status.
The majority of dietary interventions with ketogenic and low-carbohydrate diets has focused
on weight loss as the primary outcome in overweight and obese individuals. However, in recent
years evidence has been mounting that the location and quality of adipose tissue (AT) play a
more important role in manifestation of CM risk than quantity of AT alone. Detrimental health
behaviours, such as low-quality diet and low levels of physical activity seem to be important
contributors to this.
Further studies can provide vital insights into the links between diet, location-specific
adipose tissue, CM risk factors and health-related behaviours.
Therefore this 8-weeks randomised pilot study will investigate the impact of either following
a low-carbohydrate, high-fat diet versus following a high-carbohydrates, moderate-fat diet
(UK dietary guidelines) on cardiometabolic risk markers and associated behaviours in a
normal-weight and overweight adult population aged 19 - 64 at potential risk of CMD.
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