CALIBER (Carbohydrates, Lipids and Biomarkers of Traditional and Emerging Cardiometabolic Risk Factors) Phase 1: A Pilot Study in Normal-weight and Overweight Adults.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Body composition - Bioelectrical impedance
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Due to the nature of the low-carbohydrate, high-fat and high-carbohydrate, moderate-fat diets masking is not feasible.
Eligibility Criteria
- Ages
- 19 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Low-carbohydrate, high-fat
Participants adhering to low-carbohydrate, high-fat diet for 8 weeks.
Intervention: Low-carbohydrate, high-fat (Other)
High-carbohydrate, moderate fat
Participants following high-carbohydrate, moderate-fat diet for 8 weeks.
Intervention: High-carbohydrate, moderate-fat (Other)
Outcomes
Primary Outcomes
Body composition - Bioelectrical impedance
Time Frame: 8 weeks
Lean mass, fat mass and adipose tissue location and distribution
Tumor necrosis factor alpha and Interleukin 6
Time Frame: 8 weeks
Measured in μg/mL
Serum lipid profile
Time Frame: 8 weeks
Total cholesterol, HDL-C, LDL-C, non-HDL cholesterol, small-dense LDL-C and triglycerides measured in mmol/L
Blood glucose
Time Frame: 8 weeks
Measured in mmol/L
Inflammatory markers, such as CRP
Time Frame: 8 weeks
Measured in mg/L
Adiponectin
Time Frame: 8 weeks
Measured in μg/mL
Body composition - Anthropometrics
Time Frame: 8 weeks
Waist, hip, neck, thigh and calf circumference measured in cm
Systolic and diastolic blood pressure
Time Frame: 8 weeks
Measured in mmHg
Fibroblast growth factor 21 (FGF21).
Time Frame: 8 weeks
Measured in pg/mL
Secondary Outcomes
- Food cravings(8 weeks)
- Cognition(8 weeks)
- Adherence to fibre recommendations(8 weeks)
- Impact on physical activity patterns(8 weeks)
- Adherence to dietary guidelines(8 weeks)
- Clinical traditional and emerging markers of dietary intake(8 weeks)
- Satiety(8 weeks)
- Adherence to assigned diet(8 weeks)
- Adherence to low-carbohydrate diet(8 weeks)
- Experience with either low-carbohydrate, high-fat or high-carbohydrate, moderate-fat diet(8 weeks)
- Adherence to taking dietary supplement for low-carbohydrate, high-fat group(8 weeks)
Investigators
Tanja Harrison
PhD Researcher and Registered Associate Nutritionist
Liverpool John Moores University
