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Clinical Trials/NCT03257085
NCT03257085CompletedNot Applicable

CALIBER (Carbohydrates, Lipids and Biomarkers of Traditional and Emerging Cardiometabolic Risk Factors) Phase 1: A Pilot Study in Normal-weight and Overweight Adults.

Liverpool John Moores University2 sites in 1 country15 target enrollmentStarted: March 9, 2017Last updated:
Conditions
Interventions

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

Experimental

Participants adhering to low-carbohydrate, high-fat diet for 8 weeks.

Intervention: Low-carbohydrate, high-fat (Other)

High-carbohydrate, moderate fat

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tanja Harrison

PhD Researcher and Registered Associate Nutritionist

Liverpool John Moores University

Study Sites (2)

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