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临床试验/NCT03257085
NCT03257085已完成不适用

CALIBER (Carbohydrates, Lipids and Biomarkers of Traditional and Emerging Cardiometabolic Risk Factors) Phase 1: A Pilot Study in Normal-weight and Overweight Adults.

Liverpool John Moores University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Body composition - Bioelectrical impedance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

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

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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
  • •Inclusion Criteria cohort 2:
  • •BMI 18.5 - 29.9kg/m2
  • •Aged 19 - 64
  • •White-Caucasian
  • •Exclusion Criteria cohort 2:
  • •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

研究组 & 干预措施

Low-carbohydrate, high-fat

Experimental

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

干预措施: Low-carbohydrate, high-fat (Other)

High-carbohydrate, moderate fat

Experimental

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

干预措施: High-carbohydrate, moderate-fat (Other)

结局指标

主要结局

Body composition - Bioelectrical impedance

时间窗: 8 weeks

Lean mass, fat mass and adipose tissue location and distribution

Tumor necrosis factor alpha and Interleukin 6

时间窗: 8 weeks

Measured in μg/mL

Serum lipid profile

时间窗: 8 weeks

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

Blood glucose

时间窗: 8 weeks

Measured in mmol/L

Inflammatory markers, such as CRP

时间窗: 8 weeks

Measured in mg/L

Adiponectin

时间窗: 8 weeks

Measured in μg/mL

Body composition - Anthropometrics

时间窗: 8 weeks

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

Systolic and diastolic blood pressure

时间窗: 8 weeks

Measured in mmHg

Fibroblast growth factor 21 (FGF21).

时间窗: 8 weeks

Measured in pg/mL

次要结局

  • Food cravings(8 weeks)
  • Cognition(8 weeks)
  • Adherence to fibre recommendations(8 weeks)
  • Impact on physical activity patterns(8 weeks)
  • Clinical traditional and emerging markers of dietary intake(8 weeks)
  • Satiety(8 weeks)
  • Adherence to dietary guidelines(8 weeks)
  • Adherence to assigned diet(8 weeks)
  • Adherence to low-carbohydrate diet(8 weeks)
  • Experience with either low-carbohydrate, high-fat or high-carbohydrate, moderate-fat diet(8 weeks)
  • Adherence to taking dietary supplement for low-carbohydrate, high-fat group(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tanja Harrison

PhD Researcher and Registered Associate Nutritionist

Liverpool John Moores University

研究点 (1)

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