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

March 7, 2018 updated by: Tanja Harrison, Liverpool John Moores University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L17 6BD
        • Liverpool John Moores University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Low-carbohydrate, high-fat
Participants adhering to low-carbohydrate, high-fat diet for 8 weeks.
Other: Low-carbohydrate, high-fat
Participants following low-carbohydrate, high-fat diet for 8 weeks.
Other Names:
  • CALIBER LCHF
EXPERIMENTAL: High-carbohydrate, moderate fat
Participants following high-carbohydrate, moderate-fat diet for 8 weeks.
Other: High-carbohydrate, moderate-fat
Participants following high-carbohydrate, moderate-fat diet (UK dietary guidelines) for 8 weeks.
Other Names:
  • CALIBER HCMF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
8 weeks
Blood glucose
Time Frame: 8 weeks
Measured in mmol/L
8 weeks
Systolic and diastolic blood pressure
Time Frame: 8 weeks
Measured in mmHg
8 weeks
Inflammatory markers, such as CRP
Time Frame: 8 weeks
Measured in mg/L
8 weeks
Adiponectin
Time Frame: 8 weeks
Measured in μg/mL
8 weeks
Fibroblast growth factor 21 (FGF21).
Time Frame: 8 weeks
Measured in pg/mL
8 weeks
Tumor necrosis factor alpha and Interleukin 6
Time Frame: 8 weeks
Measured in μg/mL
8 weeks
Body composition - Bioelectrical impedance
Time Frame: 8 weeks
Lean mass, fat mass and adipose tissue location and distribution
8 weeks
Body composition - Anthropometrics
Time Frame: 8 weeks
Waist, hip, neck, thigh and calf circumference measured in cm
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical traditional and emerging markers of dietary intake
Time Frame: 8 weeks
Fibroblast growth factor 21 and serum metabolites
8 weeks
Food cravings
Time Frame: 8 weeks
Measured via self-reported questionnaire
8 weeks
Satiety
Time Frame: 8 weeks
Assessed via serum leptin levels (ng/mL)
8 weeks
Cognition
Time Frame: 8 weeks
Assessed via self-reported questionnaire
8 weeks
Impact on physical activity patterns
Time Frame: 8 weeks
Assessed via accelerometry
8 weeks
Adherence to assigned diet
Time Frame: 8 weeks
Measured via 4-day food diaries
8 weeks
Adherence to dietary guidelines
Time Frame: 8 weeks
Measured via diet quality score assessment
8 weeks
Adherence to low-carbohydrate diet
Time Frame: 8 weeks
Measured via blood ketones (mmol/L)
8 weeks
Adherence to fibre recommendations
Time Frame: 8 weeks
Measured via structured questionnaires
8 weeks
Adherence to taking dietary supplement for low-carbohydrate, high-fat group
Time Frame: 8 weeks
Measured via counting of number of multi-vitamin and mineral supplements consumed
8 weeks
Experience with either low-carbohydrate, high-fat or high-carbohydrate, moderate-fat diet
Time Frame: 8 weeks
Assessed via semi-structured interview
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liverpool John Moores University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Liverpool Hope University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ian G Davies, PhD, Liverpool John Moores University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CALIBER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiometabolic Risk

Clinical Trials on Low-carbohydrate, high-fat

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings