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临床试验/NCT06668714
NCT06668714招募中不适用

Does Co-administration of Lactate Affect Postprandial Nutrient Absorption and Fat Disposition?

University of Aarhus1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年8月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Difference in meal fat uptake in heart tissue between CTR and LAC following a liquid test meal

研究概览

简要总结

Aim To investigate the effects of oral lactate administration on nutrient absorption and substrate utilization in individuals with pre-diabetes.

Hypothesis The addition of lactate to a meal improves postprandial lipemia and reduces lipid storage in ectopic tissues through delayed absorption and faster removal of circulating lipids from circulation.

详细描述

A recent study showed that oral lactate administration slowed gastric emptying, increased the feeling of being full, induced satiety, and decreased the anticipated future food intake compared with intravenous administration. This shows that lactate has direct effects in the GI tract, which could improve substrate utilization after meals and thereby improve metabolic health. However, it remains unknown whether oral lactate administration has similar effects in other populations (i.e. individuals with obesity) and in relation to a meal.

To address these potential effects, the investigators aim to implement and validate a new tracer method in Denmark to measure meal fat partitioning using an orally ingested fluorine-labeled fatty acid analog (18F-fluoro-6-thiaheptadecanoic acid, 18F-FTHA) combined with positron emission tomography coupled to computed tomography (PET-CT). In a previous study using the aforementioned method, it has been shown that individuals with an impaired glucose tolerance have increased myocardial fatty acid uptake, not explained by potential confounding factors and that this is associated with a reduced systolic ejection fraction. In a recent study, it was found that subjects with insulin resistance have a higher uptake of free fatty acids in visceral adipose tissue compared with subjects without insulin resistance.

This method will enable the investigators to determine how the addition of lactate to a test meal will affect meal fat partitioning. Previous methods for determining fatty acid partitioning and accumulation have either been limited to only determining the accumulation in non-oxidative tissues or very invasive or difficult to perform, making this the first method to non-invasively simultaneously measure the partitioning of meal fatty acids in all human organs.

Work package 1 (WP1):

The investigators will also include 8 healthy individuals (HbA1c mmol/mol< 39, age 50+ years) as a healthy control group, who will be studied twice in a randomized trial following ingestion of a liquid test meal to determine the differences in meal fat partitioning between insulin-sensitive and insulin-resistant individuals and to determine the intraindividual variation in meal fat partitioning. Furthermore, the extra PET scans performed in the healthy individuals will be used for precise quantification of the radiation exposure with the PET method (dosimetry) and validation of the PET method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •50+ years
  • •Written and oral consent
  • •HbA1c 39-47 mmol/L

排除标准

  • •Medicine with an impact on blood glucose and glucose metabolism.
  • •Newly started medicine (&amp;lt;3 months prior to the inclusion time)
  • •Medicine changes (&amp;lt;3 months prior to the inclusion time and planned changes during the trial)
  • •Affected screening blood sample as evaluated by PI
  • •Hba1c > 47
  • •Allergy to paracetamol
  • •Doesn't speak or understand Danish
  • •Special diets
  • •The eight healthy individuals will be included by the same criteria except for not having pre-diabetes

研究组 & 干预措施

Placebo pre-diabetes

Placebo Comparator

干预措施: Placebo + mixed meal (Combination Product)

Placebo pre-diabetes

Placebo Comparator

干预措施: Lactate + mixed meal (Combination Product)

Placebo pre-diabetes

Placebo Comparator

干预措施: PET-scan (Radiation)

Lactate pre-diabetes

Experimental

干预措施: Placebo + mixed meal (Combination Product)

Lactate pre-diabetes

Experimental

干预措施: Lactate + mixed meal (Combination Product)

Lactate pre-diabetes

Experimental

干预措施: PET-scan (Radiation)

Healthy

Active Comparator

We will include 8 healthy, normal-weight individuals (BMI 20-25 kg/m2, age 50+ years) as a healthy control group, who will be studied twice following ingestion of a liquid test meal to determine the differences in meal fat partitioning between insulin-sensitive and insulin-resistant individuals and to determine the intraindividual variation in meal fat partitioning. Furthermore, the extra PET scans performed in the healthy individuals will be used for precise quantification of the radiation exposure with the PET method (dosimetry) and validation of the PET method.

干预措施: PET-scan (Radiation)

Healthy

Active Comparator

We will include 8 healthy, normal-weight individuals (BMI 20-25 kg/m2, age 50+ years) as a healthy control group, who will be studied twice following ingestion of a liquid test meal to determine the differences in meal fat partitioning between insulin-sensitive and insulin-resistant individuals and to determine the intraindividual variation in meal fat partitioning. Furthermore, the extra PET scans performed in the healthy individuals will be used for precise quantification of the radiation exposure with the PET method (dosimetry) and validation of the PET method.

干预措施: Mixed meal with 18F-FTHA (Combination Product)

结局指标

主要结局

Difference in meal fat uptake in heart tissue between CTR and LAC following a liquid test meal

时间窗: 5-6 hours

The investigators will use a dynamic whole-body PET scan to determine dietary fatty acid trapping and distribution by measuring available 18F-FTHA-tracer in blood coupled with measurement of radioactivity in different organs. The investigators will also use the 18F-FTHA standardized uptake value (SUV) to evaluate dietary fatty acid trapping and distribution, to be able to compare our results with former studies using the 18F-FTHA method.

次要结局

  • Difference in meal fat uptake in skeletal muscle, liver, subcutaneous fat, heart and visceral fat(7 hours)
  • Difference in absorption rate and distribution of free fatty acids.(7 hours)
  • Difference in subjective appetite sensation(7 hours)
  • Difference in ventricular emptying rate(7 hours)

研究者

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

Natasa Brkovic Zubanovic

Principal Investigator

University of Aarhus

研究点 (1)

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