ISRCTN68451814进行中（未招募）Unknown
The effect of diet on immune and vaccine responses in people living with obesity in transitioning communities.
Radboud University Nijmegen Medical Centre0 个研究点目标入组 150 人开始时间: 2024年1月10日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 27/02/2024:
- •1. Age between 30 and 60 years·
- •2. BMI > 25 kg/m² at screening (‘overweight/obesity group) or 18.5–24.9 kg/m² at screening (‘normal weight controls)
- •3. Westernized-style diet as a regular diet, as assessed one week prior to recruitment while participants were taking their usual diets (using a 24-hour dietary recall on three non-consecutive days, including one weekend)·
- •4. Taking alcoholic drinks but not fermented banana beverage (Consuming a fermented banana beverage less than twice a week).
- •5. For female: practising highly effective birth control method: this means one of the two:
- •5.1. Currently using hormonal contraceptive, or
- •5.2. Providing a consent to oblige to a double-barrier method” (i.e. 1 physical barrier method plus the use of a chemical barrier, for example, male condom plus spermicide, Types of barrier methods include condoms, diaphragms, cervical caps, and the contraceptive sponge) to prevent conception during the time of the study.
- •Previous inclusion criteria:
- •1. Age between 35 and 60 years·
- •2. BMI > 27 kg/m² at screening (‘overweight/obesity group) or 18.5–24.9 kg/m² at screening (‘normal weight controls)
- •3. Westernized-style diet as a regular diet, as assessed one week prior to recruitment while participants were taking their usual diets (using a 24-hour dietary recall on three non-consecutive days, including one weekend)·
- •4. Taking alcoholic drinks but not fermented banana beverage (Consuming a fermented banana beverage less than twice a week).
- •5. For female: practising highly effective birth control method: this means one of the two:
- •5.1. Currently using hormonal contraceptive, or
- •5.2. Providing a consent to oblige to a double-barrier method” (i.e. 1 physical barrier method plus the use of a chemical barrier, for example, male condom plus spermicide, Types of barrier methods include condoms, diaphragms, cervical caps, and the contraceptive sponge) to prevent conception during the time of the study.
排除标准
- •Current exclusion criteria as 27/02/2024:
- •1. A Positive HIV test.
- •2. A Positive malaria test.
- •3. A Positive urinary pregnancy test.
- •4. Abnormal blood pressure (Systolic <90 but >140 mmHg, Diastolic < 60 but >100 mmHg).
- •5. Diabetic patients (RBG > 11.1 mmol/L).
- •6. History of fever at least 30 days prior to enrolment.
- •7. Past medical history of a chronic illness.
- •8. History of antibiotic therapy or any immune modulatory drugs 3 weeks prior to enrolment.
- •9. Currently breastfeeding
- •10. Positive history of mental illness.
- •11. Positive history of alcohol or illicit drug use.
- •12. Currently enrolled in a weight loss program or partaking in another clinical trial.
- •Previous exclusion criteria:
- •1. A Positive HIV test.
- •2. A Positive malaria test.
- •3. A Positive urinary pregnancy test.
- •4. Abnormal blood pressure (Systolic <90 but >140 mmHg, Diastolic < 60 but >100 mmHg).
- •5. Diabetic patients (RBG > 11.1 mmol/L).
- •6. History of fever at least 30 days prior to enrolment.
- •7. Past medical history of a chronic illness.
- •8. History of antibiotic therapy or any immune modulatory drugs 3 weeks prior to enrolment.
- •9. Currently breastfeeding or in menopause.
- •10. Positive history of mental illness.
- •11. Positive history of alcohol or illicit drug use.
- •12. Currently enrolled in a weight loss program or partaking in another clinical trial.
研究者
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