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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2017-12-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Low-Calorie Diet in People With Prediabetes/Metabolic Syndrome

NCT04786418

Obesity NAFLD Fatty Liver +2 more

COMPLETED NA

The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism

NCT03145350

Fat; Liver NAFLD

COMPLETED NA

Effects of Three Dietary Strategies on Body Composition and Metabolic Health in Adults With Overweight or Obesity

NCT07314177

Overweight (BMI > 25) Obesity &Amp; Overweight Metabolic Syndrome (MetS) +1 more

COMPLETED NA

Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism

NCT03090347

NAFLD Nutrient; Excess

UNKNOWN NA

Development of a Nutrigenetic Test for Personalized Prescription of Body Weight Loss Diets (Obekit)

NCT02737267

Body Weight Changes

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiometabolic Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised pilot study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Due to the nature of the low-carbohydrate, high-fat and high-carbohydrate, moderate-fat diets masking is not feasible.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low-carbohydrate, high-fat

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

Group Type EXPERIMENTAL

Low-carbohydrate, high-fat

Intervention Type OTHER

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

High-carbohydrate, moderate fat

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

Group Type EXPERIMENTAL

High-carbohydrate, moderate-fat

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low-carbohydrate, high-fat

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

Intervention Type OTHER

High-carbohydrate, moderate-fat

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CALIBER LCHF CALIBER HCMF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

1. BMI 18.5 - 29.9kg/m2
2. Aged 19 - 64
3. White-Caucasian

Exclusion Criteria

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

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes