NCT07447440招募中不适用
Unraveling the Role of Pro-Resolving Lipid Mediators of Inflammation and Their Receptors in Obesity-Associated Diseases: New Therapeutic Approaches for Maresin 1 (RESOLBE)
Clinica Universidad de Navarra, Universidad de Navarra2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月15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
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lipid mediators profile
研究概览
简要总结
The main objective of this project is to determine the possible association between the levels of certain bioactive lipids, which the body produces from dietary fatty acids, and tumor characteristics in breast cancer patients, as well as their relationship with overweight/obesity.
Specific objectives are:
- To analyse anthropometric and body composition changes.
- To evaluate physical activity level.
- To determine dietary profile.
- To determine the adherence to Mediterranean dietary pattern.
- To assess the quality of life.
- To determine levels of specialized pro-resolving lipid mediators
The target sample size is 60 subjects. Participants will be allocated in four groups:
- Group 1: Postmenopausal healthy women with overweight/obesity (n=15)
- Group 2: Postmenopausal healthy women with normoweight (n=15)
- Group 3: Postmenopausal women with breast cancer and overweight/obesity (n=15)
- Group 4: Postmenopausal women with breast cancer and normoweight (n=15)
详细描述
Volunteers who wish to participate in the study will be informed about the procedures of the study. Volunteers who agree to participate will sign the informed consent form.
Participants from Group 1 and Group 2 will visit nutritional intervention unit at Clinical Investigation Day 1 (day 1) and at Clinical Investigation Day 2 (day 8).
Participants from Group 3 and Group 4 will visit nutritional intervention unit after surgery for tumor removal, at Clinical Investigation Day 1 (day 1), at Clinical Investigation Day 2 (day 8), at Clinical Investigation Day 3 (1 year) and at Clinical Investigation Day 4 (1 year + day 8).
- Clinical Investigation Day 1 and 3: anthropometric and body composition measurements, delivery of questionnaires , blood extraction, placement of accelerometer .
- Clinical Investigation Day 2 and 4: reception of accelerometer and collection of completed questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HEALTHY PARTICIPANTS:
- •Inclusion Criteria:
- •Postmenopause (al least 1 year).
- •Normoweight or overweight/obesity.
- •No personal history of cancer.
- •Stable weight over the last 3 months (±5%).
- •Willing to sign the informed consent and comply with all study procedures.
排除标准
- •Personal history of cancer.
- •Current weight loss treatment (diet, supplementation, surgery, others...).
- •Bariatric surgery.
- •No stable pharmacological treatment for at least 3 months.
- •Diabetes treatment and hormone replacement therapy.
- •Relevant functional or structural abnormalities of the gastrointestinal tract, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc.
- •High alcohol intake, more than 14 units per week for women and 20 units per week for men.
- •Surgical interventions resulting in permanent sequelae of the gastrointestinal tract.
- •Liver disease, except for non-alcoholic fatty liver disease.
- •Cognitive and/or psychiatric impairment.
- •Poor compliance or difficulty following study procedures.
- •BREAST CANCER PARTICIPANTS:
- •Inclusion Criteria:
- •Postmenopause (at least 1 year).
- •Normoweight or overweight/obesity.
- •Luminal subtype breast cancer, stages I-II, who require tumor resection and do not require preoperative treatment.
- •Willing to sign the informed consent and comply with all study procedures.
- •Exclusion Criteria:
- •Luminal subtype breast cancer stages over than II or other type of breast cancer.
- •Require preoperative treatment.
研究组 & 干预措施
Group 1
Postmenopausal healthy women with overweight/obesity.
干预措施: Observational study (baseline) (Other)
Group 2
Postmenopausal healthy women with normoweight.
干预措施: Observational study (baseline) (Other)
Group 3
Postmenopausal women with breast cancer and overweight/obesity
干预措施: Observational study (baseline and 1 year) (Other)
Group 4
Postmenopausal women with breast cancer and normoweight.
干预措施: Observational study (baseline and 1 year) (Other)
结局指标
主要结局
Lipid mediators profile
时间窗: Clinical Investigation Day 1 and Clinical Investigation Day 3
Lipid mediators will be analysed by targeted lipidomic method.
次要结局
- Body weight(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Height(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Body mass index(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Hip circumference(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Waist circumference(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Leg circumference(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Appendicular Skeletal Muscle Mass(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Fat mass percentage(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Fat mass (g)(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Lean mass(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Fat-free mass(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Visceral adipose tissue(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Android mass(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Android fat(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Subcutaneous adipose tissue(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Total bone mineral density(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Forearm bone mineral density(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Lumbar spine (L1-L4) bone mineral density(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Femoral neck bone mineral density(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Total femur bone mineral density(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Glucose concentration(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Insulin concentration(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Adiponectin(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- HOMA index (Homeostatic Model Assessment index)(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Total cholesterol(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- High density lipoprotein cholesterol (HDL-c)(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Low lipoprotein cholesterol (LDL-c)(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Triglyceride levels(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Leptin(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Tumor necrosis factor alpha (TNF-alpha)(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Free fatty acids(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Lipocalin(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- IL-6 (interleukine-6)(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- IL-8 (interleukine-8)(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Dietary profile(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Mental and physical quality of life(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Adherence to Mediterranean dietary pattern(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Physical activity level by acelerometers(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
- Physical activity level by questoinnaire(Clinical Investigation Day 1 and Clinical Investigation Day 3.)
研究者
研究点 (2)
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