Cardiometabolic RiskCALIBERNCT03257085
CALIBER Phase 1: A Pilot Study in Normal-weight and Overweight Adults.
A study testing Low-carbohydrate, high-fat and High-carbohydrate, moderate-fat in people with Cardiometabolic Risk, run by Liverpool John Moores University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk
- What is being tested?
- Low-carbohydrate, high-fat and High-carbohydrate, moderate-fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2017to 8 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 16Show fewer
- 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.
- BMI 18.5 - 29.9kg/m2
- Aged 19 - 64
- White-Caucasian
Who cannot join
- 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
Show all 22Show fewer
- Taking blood pressure-lowering medication
- Taking blood glucose-lowering medication
- Taking dietary supplements
- Suffering from an eating disorder
- Current or previous renal impairment
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L17 6BD
About this study
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.
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.
Read the 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.
- Conditions
- Cardiometabolic Risk
- Being tested
- Low-carbohydrate, high-fat, High-carbohydrate, moderate-fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-carbohydrate, high-fatOther
Also called CALIBER LCHF
Participants following low-carbohydrate, high-fat diet for 8 weeks.
High-carbohydrate, moderate-fatOther
Also called CALIBER HCMF
Participants following high-carbohydrate, moderate-fat diet (UK dietary guidelines) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low-carbohydrate, high-fat | Experimental | Participants adhering to low-carbohydrate, high-fat diet for 8 weeks. Receives: Other: Low-carbohydrate, high-fat |
| High-carbohydrate, moderate fat | Experimental | Participants following high-carbohydrate, moderate-fat diet for 8 weeks. Receives: Other: High-carbohydrate, moderate-fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lipid profile
Total cholesterol, HDL-C, LDL-C, non-HDL cholesterol, small-dense LDL-C and triglycerides measured in mmol/L
Measured: 8 weeks
Blood glucose
Measured in mmol/L
Measured: 8 weeks
Systolic and diastolic blood pressure
Measured in mmHg
Measured: 8 weeks
Inflammatory markers, such as CRP
Measured in mg/L
Measured: 8 weeks
Adiponectin
Measured in μg/mL
Measured: 8 weeks
Fibroblast growth factor 21 (FGF21).
Measured in pg/mL
Measured: 8 weeks
Tumor necrosis factor alpha and Interleukin 6
Measured in μg/mL
Measured: 8 weeks
Body composition - Bioelectrical impedance
Lean mass, fat mass and adipose tissue location and distribution
Measured: 8 weeks
Body composition - Anthropometrics
Waist, hip, neck, thigh and calf circumference measured in cm
Measured: 8 weeks
Secondary outcomes (11)
Clinical traditional and emerging markers of dietary intake
Fibroblast growth factor 21 and serum metabolites
Measured: 8 weeks
Food cravings
Measured via self-reported questionnaire
Measured: 8 weeks
Satiety
Assessed via serum leptin levels (ng/mL)
Measured: 8 weeks
Cognition
Assessed via self-reported questionnaire
Measured: 8 weeks
Impact on physical activity patterns
Assessed via accelerometry
Measured: 8 weeks
Adherence to assigned diet
Measured via 4-day food diaries
Measured: 8 weeks
Adherence to dietary guidelines
Measured via diet quality score assessment
Measured: 8 weeks
Adherence to low-carbohydrate diet
Measured via blood ketones (mmol/L)
Measured: 8 weeks
Adherence to fibre recommendations
Measured via structured questionnaires
Measured: 8 weeks
Adherence to taking dietary supplement for low-carbohydrate, high-fat group
Measured via counting of number of multi-vitamin and mineral supplements consumed
Measured: 8 weeks
Experience with either low-carbohydrate, high-fat or high-carbohydrate, moderate-fat diet
Assessed via semi-structured interview
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start9 Mar 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Hope University
- Responsible party
- Principal investigator, Tanja Harrison, Liverpool John Moores University
- Investigators
- Ian G Davies, PhD, Study chair, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257085
- Sponsor's protocol ID
- CALIBER
- Acronym
- CALIBER
- Status last verified
- Mar 2018
- First submitted
- 14 Aug 2017
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03257085
- Acronym / sponsor ID
- CALIBER / CALIBER
- Conditions
- Cardiometabolic Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Liverpool Hope University
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised pilot study
| Arm | Type | Receives |
|---|---|---|
| Low-carbohydrate, high-fat | Experimental | Other: Low-carbohydrate, high-fatParticipants adhering to low-carbohydrate, high-fat diet for 8 weeks. |
| High-carbohydrate, moderate fat | Experimental | Other: High-carbohydrate, moderate-fatParticipants following high-carbohydrate, moderate-fat diet for 8 weeks. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- BMI 18.5 - 29.9kg/m2
- Aged 19 - 64
- White-Caucasian
- Score of ≥4 from a combination of risk markers, including
- BMI 18.5 - 29.9kg/m2
Key exclusion criteria (22 listed)
- Smoker
- Vegetarian or vegan
- Suffering from food allergies or intolerances
- Drinking alcohol above recommended UK government guidelines
- Previous diagnosis of CM disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-carbohydrate, high-fatAlso: CALIBER LCHFParticipants following low-carbohydrate, high-fat diet for 8 weeks. | Other | Low-carbohydrate, high-fat |
| High-carbohydrate, moderate-fatAlso: CALIBER HCMFParticipants following high-carbohydrate, moderate-fat diet (UK dietary guidelines) for 8 weeks. | Other | High-carbohydrate, moderate fat |
Primary outcome
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
Systolic and diastolic blood pressure
Time frame: 8 weeks
Measured in mmHg
Inflammatory markers, such as CRP
Time frame: 8 weeks
Measured in mg/L
Adiponectin
Time frame: 8 weeks
Measured in μg/mL
Fibroblast growth factor 21 (FGF21).
Time frame: 8 weeks
Measured in pg/mL
Tumor necrosis factor alpha and Interleukin 6
Time frame: 8 weeks
Measured in μg/mL
Body composition - Bioelectrical impedance
Time frame: 8 weeks
Lean mass, fat mass and adipose tissue location and distribution
Body composition - Anthropometrics
Time frame: 8 weeks
Waist, hip, neck, thigh and calf circumference measured in cm
11 secondary outcomes
Clinical traditional and emerging markers of dietary intake
Time frame: 8 weeks
Food cravings
Time frame: 8 weeks
Satiety
Time frame: 8 weeks
Cognition
Time frame: 8 weeks
Impact on physical activity patterns
Time frame: 8 weeks
Adherence to assigned diet
Time frame: 8 weeks
Adherence to dietary guidelines
Time frame: 8 weeks
Adherence to low-carbohydrate diet
Time frame: 8 weeks
Adherence to fibre recommendations
Time frame: 8 weeks
Adherence to taking dietary supplement for low-carbohydrate, high-fat group
Time frame: 8 weeks
Experience with either low-carbohydrate, high-fat or high-carbohydrate, moderate-fat diet
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- 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), 1617Link provided by the sponsor.
- 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),Link provided by the sponsor.
- De Larochellière, E. et al. (2014) Visceral/epicardial adiposity in nonobese and apparently healthy young adults: association with the cardiometabolic profile AthLink provided by the sponsor.
- 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), 191-215Link provided by the sponsor.
- 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), 1132-1137Link provided by the sponsor.
- Gardner, C. (2012) Tailoring dietary approaches for weight loss Int J Obes Suppl 2(Suppl 1), S11-S15Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian G Davies, PhD study chair
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-carbohydrate, high-fat and High-carbohydrate, moderate-fat in people with Cardiometabolic Risk, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum lipid profile (time frame: 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018; AzTrials last refreshed its copy on 2 Nov 2026.