The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change in food intake at an ad libitum meal during GLP-1 infusion
研究概览
简要总结
The goal of this parallel-group, two-arm, assessor-blinded, randomised clinical trial is to investigate the effects of reducing physical activity on food intake and satiety in physically active and healthy males, 40-55 years of age.
The main questions it aims to answer are:
- Does physical inactivity affect GLP-1 stimulated food intake?
- Does physical inactivity affect food preferences, satiety and other mechanisms supporting appetite regulation?
Participants will be randomised (1:1) to two weeks of either no intervention (control group) or inactivity. Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day.
Researchers will compare the inactivity group to the control group to see if physical inactivity impairs appetite regulation.
详细描述
To contextualize the changes in ad libitum food intake driven by two weeks of physical inactivity, a sub-study will assess the effect of GLP-1 infusion on ad libitum food intake compared with a saline control in 20 participants included based on same eligibility criteria as in the main study. The estimated GLP-1 induced change in ad libitum food intake will be descriptively compared to the estimated GLP-1 + inactivity induced change in ad libitum food intake (main-study) to provide context for any attenuation in appetite suppression observed in the main-study. Outcomes related to subjective appetite measures (hunger, satiety, and food preference) will also be assessed in this way.
The primary hypothesis is that GLP-1 infusion will suppress appetite and reduce ad libitum food intake compared with saline control. The secondary hypothesis is that GLP-1 infusion will diminish subjective feelings of hunger and increase satiety.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 40 years and ≤ 55 years
- •Body mass index (BMI) > 20 and < 25 kg/m2
- •Physical activity level should as a minimum include: Active commuting by biking a minimum of 10 km, four days per week or an equivalent amount of other physical activity four days per week.
- •Healthy (based on self-reporting, pre-study medical examination and biochemical screening)
- •Can adhere to two weeks of inactivity (refrain from running, cycling and all other exercise while reducing steps to max. 1500 pr. day)
- •No change in body weight > 5 kg within the last 6 months
- •Eats breakfast and lunch daily
- •Does not follow specific dietary restrictions
- •No disliking of spaghetti bolognese
- •No diagnosis of psychiatric disorder or treatment with anti-depressant or anti-psychotic medication
- •No history of suicidal behavior or ideations.
- •No previous surgical treatment for obesity
- •No cardiovascular disease
- •No rheumatologic disease
- •No metabolic/endocrine disease
- •No liver disease (ASAT or ALAT >2x upper normal range)
- •No other chronic disease
- •No elite sports
- •No frequent or chronic use of medications affecting bodyweight, physical performance, or inflammation (NSAIDS, DMARDS, corticosteroids)
- •No current infection
- •No history of cancer
- •No anemia (hematocrit <33%)
- •No participation in other research intervention studies
排除标准
- •Clinical or biochemical signs of disease
- •HbA1c > 39 mmol/mol
- •Unable to allocate the needed time to fulfill the intervention
- •Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions
研究组 & 干预措施
Inactivity
Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day.
干预措施: Inactivity (Behavioral)
Control
Participants will be instructed to maintain habitual physical activity and dietary habits.
结局指标
主要结局
The change in food intake at an ad libitum meal during GLP-1 infusion
时间窗: From baseline (week 0) to follow-up (week 2).
Food intake will be evaluated as ingested food in grams
次要结局
- The change in subjective feeling of satiety(From baseline (week 0) to follow-up (week 2))
- The change in subjective experience of severity and type of food cravings(From baseline (week 0) to follow-up (week 2))
- The change in subjective felling of hunger(From baseline (week 0) to follow-up (week 2))
- The change in satiety composite appetite score(From baseline (week 0) to follow-up (week 2))
- The change in preference for unhealthy food ( combined score for high fat food, savory food, and sweet food).(From baseline (week 0) to follow-up (week 2))
- Sub study(Sub study)
研究者
Grit Elster Legård
Primary Investigator
Rigshospitalet, Denmark