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

Cardiometabolic Risk Clinical Trial

— CALIBER  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257085
• Other study ID #: CALIBER
• Status: Completed
• Phase: N/A
• First received: August 14, 2017
• Last updated: March 7, 2018
• Start date: March 9, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: March 2018
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria cohort 1:

1. BMI 18.5 - 29.9kg/m2

2. Aged 19 - 64

3. White-Caucasian

4. 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:

1. Smoker

2. Vegetarian or vegan

3. Suffering from food allergies or intolerances

4. Drinking alcohol above recommended UK government guidelines

5. Previous diagnosis of CM disease

6. Taking lipid-lowering medication

7. Taking blood pressure-lowering medication

8. Taking blood glucose-lowering medication

9. Taking dietary supplements

10. Suffering from an eating disorder

11. Current or previous renal impairment

Inclusion Criteria cohort 2:

1. BMI 18.5 - 29.9kg/m2

2. Aged 19 - 64

3. White-Caucasian

Exclusion Criteria cohort 2:

1. Smoker

2. Vegetarian or vegan

3. Suffering from food allergies or intolerances

4. Drinking alcohol above recommended UK government guidelines

5. Previous diagnosis of CM disease

6. Taking lipid-lowering medication

7. Taking blood pressure-lowering medication

8. Taking blood glucose-lowering medication

9. Taking dietary supplements

10. Suffering from an eating disorder

11. Current or previous renal impairment

Related Conditions & MeSH terms

• Cardiometabolic Risk
• Overweight

Intervention

Other:
• Low-carbohydrate, high-fat
Participants following low-carbohydrate, high-fat diet for 8 weeks.
• High-carbohydrate, moderate-fat
Participants following high-carbohydrate, moderate-fat diet (UK dietary guidelines) for 8 weeks.

Locations

Country	Name	City	State
United Kingdom	Liverpool John Moores University	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool John Moores University	Liverpool Hope University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lipid profile	Total cholesterol, HDL-C, LDL-C, non-HDL cholesterol, small-dense LDL-C and triglycerides measured in mmol/L	8 weeks
Primary	Blood glucose	Measured in mmol/L	8 weeks
Primary	Systolic and diastolic blood pressure	Measured in mmHg	8 weeks
Primary	Inflammatory markers, such as CRP	Measured in mg/L	8 weeks
Primary	Adiponectin	Measured in µg/mL	8 weeks
Primary	Fibroblast growth factor 21 (FGF21).	Measured in pg/mL	8 weeks
Primary	Tumor necrosis factor alpha and Interleukin 6	Measured in µg/mL	8 weeks
Primary	Body composition - Bioelectrical impedance	Lean mass, fat mass and adipose tissue location and distribution	8 weeks
Primary	Body composition - Anthropometrics	Waist, hip, neck, thigh and calf circumference measured in cm	8 weeks
Secondary	Clinical traditional and emerging markers of dietary intake	Fibroblast growth factor 21 and serum metabolites	8 weeks
Secondary	Food cravings	Measured via self-reported questionnaire	8 weeks
Secondary	Satiety	Assessed via serum leptin levels (ng/mL)	8 weeks
Secondary	Cognition	Assessed via self-reported questionnaire	8 weeks
Secondary	Impact on physical activity patterns	Assessed via accelerometry	8 weeks
Secondary	Adherence to assigned diet	Measured via 4-day food diaries	8 weeks
Secondary	Adherence to dietary guidelines	Measured via diet quality score assessment	8 weeks
Secondary	Adherence to low-carbohydrate diet	Measured via blood ketones (mmol/L)	8 weeks
Secondary	Adherence to fibre recommendations	Measured via structured questionnaires	8 weeks
Secondary	Adherence to taking dietary supplement for low-carbohydrate, high-fat group	Measured via counting of number of multi-vitamin and mineral supplements consumed	8 weeks
Secondary	Experience with either low-carbohydrate, high-fat or high-carbohydrate, moderate-fat diet	Assessed via semi-structured interview	8 weeks

External Links

•   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)
•   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
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•   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
•   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.