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Sweeteners and sweetness enhancers: Prolonged effects on health, obesity and safety - SWEET
niversity of Copenhagen0 个研究点目标入组 108 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •- Age: 18-65 years.
- •- BMI: *25.0 kg/m2 (no upper limit).
- •- For women: Use of contraceptive methods and not wishing/planning to become
- •pregnant the 2 years of the intervention study.
- •- Regular consumption of sugar-containing/sugar-sweetened products.
- •- Motivation and willingness to be randomized to any of the two groups and to
- •do the best to follow the given protocol.
- •- Age: 6 up to and including 12 years.
- •- BMI-for-age: >85th percentile (no upper limit).
- •- Able to participate in CID*s and the dietitian-investigator meeting (month
- •18) during normal working hours.
- •- Motivation and willingness to be randomized to any of the two groups and to
- •do the best to follow the given protocol.
- •fMRI sub-study: control group
- •- Age: 18 up to and including 65 years.
- •- BMI: *25.0 kg/m2 (no upper limit).
- •- For women: Use of contraceptive methods and not wishing/planning to become
- •pregnant the 2 years of the intervention study.
- •- Regular consumption of sugar-containing/sugar-sweetened products.
排除标准
- •Based on interview and/or questions, adults with the following issues will be
- •- Weight change (increase or decrease) >5% during the past 2 months prior to
- •- Surgical treatment of obesity.
- •- Blood donation < 3 month prior to study.
- •- Change in smoking habits during the last month. Smoking is allowed provided
- •subjects have not recently changed habits. However, smoking status is monitored
- •throughout the study and used as a confounding variable.
- •- Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic
- •units/week (women).
- •- Intensive physical training (>10 hours of per week).
- •- Self-reported eating disorders.
- •- Intolerance and allergies expected to interfere with the study.
- •- Self-reported use of drugs of abuse within previous 12 months.
- •- Night- or shift work.
- •- For women: Pregnancy, lactation.
- •- Persons who do not have access to either (mobile) phone or internet
- •- Insufficient communication with national language.
- •- Regular use of pro-/prebiotics
- •- Inability, physically or mentally, to comply with the procedures required by
- •the study protocol as evaluated by the daily study manager, site-PI, PI or
- •clinical responsible.
- •- Subject*s general condition contraindicates continuing the as evaluated by
- •the daily study manager, site-PI, PI or clinical responsible.
- •- Simultaneous participation in other clinical intervention studies.
- •Medical conditions as known by the persons:
- •- Diagnosed diabetes mellitus.
- •- Medical history of CVD
- •- Systolic BP above 160 mmHg and/or diastolic BP above 100 mmHg (measured at
- •screening) whether on or off treatment for hypertension.
- •- Significant liver disease, e.g. cirrhosis (fatty liver disease allowed).
- •- Malignancy which is currently active or in remission for less than five years
- •after last treatment (local basal and squamous cell skin cancer allowed).
- •- Active inflammatory bowel disease, celiac disease, chronic pancreatitis or
- •other disorder potentially causing malabsorption.
- •- Thyroid diseases, except those on Levothyroxine treatment of hypothyroidism
- •if the person has been on a stable dose for at least 3 months.
- •- Psychiatric illness (e.g. major depression, bipolar disorders).
- •Medication:
- •- Use currently or within the previous 3 months of prescription or over the
- •counter medication that has the potential of affecting body weight incl. food
- •supplements.
- •- Use of antibiotics during the 3 months prior to the start of the study
- •- Cholesterol or BP lowering medication, if the dose has changed during the
- •last 3 months
- •Laboratory screening:
- •If all of the above criteria are satisfied, the adult participant is eligible
- •for a laboratory screening. A blood sample is collected and immediately
- •analyzed for the following exclusion criteria:
- •- Prevalence of type 2 diabetes (Fasting Glucose * 7.0 mmol/L)
- •- Low haemoglobin levels (to predict anemia etc.)
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研究者
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