CALIBER Phase 1: A Pilot Study in Normal-weight and Overweight Adults.

NCT03257085 | Completed DMC

• 1 other identifier: CALIBER
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Risk

Outcome Measures

Primary Outcomes (9)

• Serum lipid profile

  Total cholesterol, HDL-C, LDL-C, non-HDL cholesterol, small-dense LDL-C and triglycerides measured in mmol/L

  8 weeks

• Blood glucose

  Measured in mmol/L

  8 weeks

• Systolic and diastolic blood pressure

  Measured in mmHg

  8 weeks

• Inflammatory markers, such as CRP

  Measured in mg/L

  8 weeks

• Adiponectin

  Measured in μg/mL

  8 weeks

• Fibroblast growth factor 21 (FGF21).

  Measured in pg/mL

  8 weeks

• Tumor necrosis factor alpha and Interleukin 6

  Measured in μg/mL

  8 weeks

• Body composition - Bioelectrical impedance

  Lean mass, fat mass and adipose tissue location and distribution

  8 weeks

• Body composition - Anthropometrics

  Waist, hip, neck, thigh and calf circumference measured in cm

  8 weeks

Secondary Outcomes (11)

• Clinical traditional and emerging markers of dietary intake

  8 weeks

• Food cravings

  8 weeks

• Satiety

  8 weeks

• Cognition

  8 weeks

• Impact on physical activity patterns

  8 weeks

Study Arms (2)

Low-carbohydrate, high-fat

EXPERIMENTAL

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

Other: Low-carbohydrate, high-fat

High-carbohydrate, moderate fat

EXPERIMENTAL

Participants following high-carbohydrate, moderate-fat diet for 8 weeks.

Other: High-carbohydrate, moderate-fat

Interventions

Low-carbohydrate, high-fat OTHER

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

Also known as: CALIBER LCHF

Low-carbohydrate, high-fat

High-carbohydrate, moderate-fat OTHER

Participants following high-carbohydrate, moderate-fat diet (UK dietary guidelines) for 8 weeks.

Also known as: CALIBER HCMF

High-carbohydrate, moderate fat

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• BMI 18.5 - 29.9kg/m2
• Aged 19 - 64
• White-Caucasian
• Smoker

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Liverpool Hope University: collaborator

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L17 6BD, United Kingdom

Location

Related Links

• Brehm, B. et al. (2003) A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women J Clin Endocrinol Metab 88(4), 1617
• Buyken, A., Goletzke, J., Joslowski, G., Felbick, A., Cheng, G., Herder, C. and Brand-Miller, J. (2014) Association between carbohydrate quality and inflammatory markers: systematic review of observational and interventional studies Am J Clin Nutr 99(4),
• De Larochellière, E. et al. (2014) Visceral/epicardial adiposity in nonobese and apparently healthy young adults: association with the cardiometabolic profile Ath
• Fischer, K., Pick, J., Moewes, D. and Nöthlings, U. (2015) Qualitative aspects of diet affecting visceral and subcutaneous abdominal adipose tissue: a systematic review of observational and controlled intervention studies Nutr Rev 73(4), 191-215
• Gadgil, M., Appel, L., Yeung, E., Anderson, C., Sacks, F. and Miller, E. (2013) The effects of carbohydrate, unsaturated fat, and protein intake on measures of insulin sensitivity: results from the OmniHeart trial Diabetes Care 36 (5), 1132-1137
• Gardner, C. (2012) Tailoring dietary approaches for weight loss Int J Obes Suppl 2(Suppl 1), S11-S15
• Hu, T. and Bazzano, L. (2014) The low-carbohydrate diet and cardiovascular risk factors: evidence from epidemiologic studies Nutr Metab Cardiovasc Dis 24(4), 337-343
• Hu, T., Yao, L., Reynolds, K., Niu, T., Li, S., Whelton, P., He, J., Steffen, L. and Bazzano, L. (2016) Adherence to low-carbohydrate and low-fat diets in relation to weight loss and cardiovascular risk factors Obes Sci Pract, 2(1), 24-3
• Ko, B., Park, K., Shin, S., Zaichenko, L., Davis, C., Crowell, J., Joung, H. and Mantzoros, C (2016) Diet quality and diet patterns in relation to circulating cardiometabolic biomarkers Clin Nutr. 35(2), 484-90
• Lee, M., Wu, Y. and Fried, S. (2013) Adipose tissue heterogeneity: implication of depot differences in adipose tissue for obesity complications Mol Aspects Med 34 (1), 1-11
• Lennerz, B., Alsop, D., Holsen, L., Stern, E., Rojas, R., Ebbeling, C., Goldstein, J.and Ludwig, D. (2013) Effects of dietary glycemic index on brain regions related to reward and craving in men Am J Clin Nutr 98(3), 641-647
• Allam-Ndoul, B., Guénard, F., Garneau, V., Cormier, H., Barbier, O., Pérusse, L., et al. (2016) Association between Metabolite Profiles, Metabolic Syndrome and Obesity Status. Nutrients 8(6)
• Lin, Z., Gong, Q., Wu, C., Yu, J., Lu, T., Pan, X., Lin, S. and Li, X. (2012) 'Dynamic change of serum FGF21 levels in response to glucose challenge in human J Clin Endocrinol Metab, 97(7), E1224-1228.

Study Officials

• Ian G Davies, PhD

  Liverpool John Moores University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the low-carbohydrate, high-fat and high-carbohydrate, moderate-fat diets masking is not feasible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher and Registered Associate Nutritionist

Model Details: Randomised pilot study

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 22, 2017
• Study Start: March 9, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 8, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

GB (1)