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临床试验/NCT02909894
NCT02909894已完成不适用

Investigating Whether Breaking up Sedentary Behaviour With Seated Upper Body Contractile Activity Can Regulate an Individual's Metabolic Health.

University of Leicester2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Blood glucose Area Under the Curve (AUC)

研究概览

简要总结

Research shows that sitting for long periods of time on a regular basis is bad for health and can leave individuals more susceptible to Obesity, Cardiovascular Disease, Type 2 Diabetes and premature death regardless of exercise engagement outside of these seated hours.

As sitting is so common in modern society it is vital that research explores ways to protect individuals from this worsening issue. Investigators want to see if breaking up long periods of sitting time with short, frequent bouts of light physical activity, while remaining seated, is enough to alleviate these risk factors.

详细描述

  • Familiarisation screening visit - (Visit 1) Before participating in the study, all participants will visit the exercise laboratory for a familiarisation and screening visit where they will be shown the designated experimental area, provide written informed consent and have various measurements taken.

All participants will be required to fast from 10pm onwards the evening prior to this first visit (drinking water is allowed). Participants will then be provided with a standardised breakfast on arrival (after consent has been obtained). This meal will be prescribed according to body mass and will provide approximately 8 kcals per kg of bodyweight made up of 13-14% protein, 51-52% carbohydrate and 35% fat. Typical ingredients used here will be; Plain bagels with margarine and a protein powder mixed with whole milk.

Alternative ingredients matching the nutritional content of this meal will be explored in light of special dietary preferences (i.e. vegan) or food allergies (i.e. lactose intolerance).

It is also important that participants avoid general exercise and drinking alcohol or coffee in the 48 hours (2 days) leading up to this first visit (and the remaining two visits), this will be made clear in the participant information sheet. Very strenuous exercise must be avoided 72 hours (3 days) prior.

Participants will be asked to record all food and drink consumed the day before this first visit. They will then be asked to replicate this diet the day before the remaining visits using their dietary record to guide them. Therefore, all meals leading up to each visit will be standardised and will not confound the results.

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
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the study
  • Body Mass Index: ≥ 30 kg/m2
  • Male and Female
  • Aged: ≥ 30 to ≤ 75 years of age.
  • Inactive (I.e. no habitual structured exercise).
  • Participant is able to walk (without any assistive devices)

排除标准

  • • Aged < 30 or > 75 years of age.
  • Physical condition which limits full participation in the familiarisation visit or treatment visits.
  • Active psychotic illness or other significant illness which, in the view of the investigators, would prevent full participation
  • Inability to communicate in spoken English
  • Steroid use
  • Known Type 2 Diabetes Mellitus
  • Pre-existing Cardio-vascular Disease including a previous heart attack, stroke, angina or coronary artery bypass surgery of cardiac stents.
  • Pregnancy
  • Terminal illness
  • Contraindication to gas mask procedure (I.e. Claustrophobia).
  • Chronic Obstructive Pulmonary Disease. (I.e. Chronic Bronchitis or Emphysema).

结局指标

主要结局

Blood glucose Area Under the Curve (AUC)

时间窗: Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for both of the two 7.5 hour experimental treatment conditions.

Blood glucose AUC refers to the spike of an individuals blood sugar following a meal, the aim of which is to reduce the spike and consequently reduce the area under the curve.

次要结局

  • Cognitive function - Part 3 - Trail Making(The time taken to complete this test varies between individuals but on average takes approximately 5 minutes. Participants will undertake this test in the morning, (following part 2 of the cognitive test) and also at the end of the experimental visit.)
  • Insulin Area Under the Curve (AUC)(Assessed via 10 blood samples.Two of which will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals. This will be assessed for both of the two 7.5 hour experimental treatment conditions.)
  • Cognitive function - Part 1 - Semantic verbal fluency test.(This test will only take one minute in duration. It is administered on arrival at the laboratory (approximately 8am) and will be repeated later on in the day following the last blood sample (approximately 4pm).)
  • Cognitive function - Part 4 - Rapid Visual Information Processing Test(This part of the test lasts for 5 minutes and will be administered following part 3 of the cognitive test in the morning and also at the end of the experimental day.)
  • Blood Pressure Area Under the Curve (AUC)(Blood pressure measurements will be taken prior to each blood sample, therefore 10 measurements in total. Two measurements will be taken while fasting and the remainder taken at 30, 60, 120 and 180 minutes following both breakfast and lunch meals.)
  • Cognitive function - Part 2 - Hopkins Verbal Learning test(Participants will undertake this test in the morning, following part 1 of the cognitive test (immediate recall) and also at the end of the experimental day (delayed recall). A maximum of one minute is used to recall as many words as possible.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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