Status:
COMPLETED
CALIBER Phase 1: A Pilot Study in Normal-weight and Overweight Adults.
Lead Sponsor:
Liverpool John Moores University
Collaborating Sponsors:
Liverpool Hope University
Conditions:
Cardiometabolic Risk
Eligibility:
All Genders
19-64 years
Phase:
NA
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 as...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria cohort 1:
- BMI 18.5 - 29.9kg/m2
- Aged 19 - 64
- White-Caucasian
- Score of ≥4 from a combination of risk markers, including
- Fasting glucose concentration \>5.5mmol/L = 3 points
- Waist \>102cm or 40 inches = 2 points (males)
- Waist \>94 cm or 37 inches = 1 point (males)
- Waist \>88cm or 34inches = 2 points (females)
- Waist \>80 cm or 31 inches = 1 point (females)
- Systolic blood pressure\>130mmHg = 1 point
- Diastolic BP \>85mmHg = 1 point
- HDL cholesterol concentration \<1.0mmol/L = 2 points
- Serum triglyceride concentration \>1.3mmol/L = 1 point.
- Exclusion Criteria cohort 1:
- Smoker
- Vegetarian or vegan
- Suffering from food allergies or intolerances
- Drinking alcohol above recommended UK government guidelines
- Previous diagnosis of CM disease
- Taking lipid-lowering medication
- Taking blood pressure-lowering medication
- Taking blood glucose-lowering medication
- Taking dietary supplements
- Suffering from an eating disorder
- Current or previous renal impairment
- Inclusion Criteria cohort 2:
- BMI 18.5 - 29.9kg/m2
- Aged 19 - 64
- White-Caucasian
- Exclusion Criteria cohort 2:
- Smoker
- Vegetarian or vegan
- Suffering from food allergies or intolerances
- Drinking alcohol above recommended UK government guidelines
- Previous diagnosis of CM disease
- Taking lipid-lowering medication
- Taking blood pressure-lowering medication
- Taking blood glucose-lowering medication
- Taking dietary supplements
- Suffering from an eating disorder
- Current or previous renal impairment
Exclusion
Key Trial Info
Start Date :
March 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03257085
Start Date
March 9 2017
End Date
December 8 2017
Last Update
March 8 2018
Active Locations (1)
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1
Liverpool John Moores University
Liverpool, Merseyside, United Kingdom, L17 6BD