NCT07165548招募中不适用
Evaluation of the Effect of Supplementation With Satiating Compounds Integrated Into a Hypocaloric Diet on Weight and Cardiometabolic and Osteoarticular Health in Overweight/Obese Subjects
Clinica Universidad de Navarra, Universidad de Navarra1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2025年8月20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
- 144
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
The main objective of this intervention study is to evaluate the effect of satiating protein and/or fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity.
To achieve this objective, volunteers will be instructed to consume three bars per day as part of a hypocaloric diet, in accordance with healthy nutritional guidelines, over a 12-week period.
The main questions to answer are:
- Does the regular consumption of these protein and/or fiber bars help to lose weight?
- Does the regular consumption of these protein and/or fiber bars help to improve the osteoarticular health?
- Does the regular consumption of these protein and/or fiber bars help to improve the cardiometabolic health?
The specific objectives are focused on evaluating the effects of the intervention on the following parameters:
- Weight and body composition.
- Knee joint range of motion.
- Blood biomarkers related to collagen degradation and synthesis, associated with osteoarticular health.
- Glycemic and lipid profiles, blood pressure, and biomarkers of kidney, liver, cardiovascular, and inflammatory health.
- Changes in joint discomfort (improvement or worsening).
- Adherence to the assigned intervention, including both dietary compliance and intake of the study-provided supplement.
- Satiety-related variables assessed using a visual analog scale (VAS).
- Urinary hydroxyproline and stool samples for metagenomic analysis.
- Gastrointestinal health, mental health, quality of life, and physical activity level assessed through validated questionnaires.
Target sample size is 144 subjects and participants will be allocated in four different groups:
- Group 1 (n=36): hypocaloric diet + protein and fiber supplement.
- Group 2 (n=36): hypocaloric diet + protein and fiber supplement.
- Group 3 (n=36): hypocaloric diet + fiber supplement.
- Group 4 "Placebo group" (n=36): hypocaloric diet + placebo supplement. Participants will attend the nutritional intervention unit at weeks 1, 8, and 12. A follow-up phone call will be conducted at week 4.
详细描述
Volunteers expressing interest in the study will undergo an initial eligibility assessment, either via telephone interview or by completing an online screening form (Google Form), to verify compliance with the primary inclusion criteria. Candidates meeting these criteria will be invited to attend an information and screening visit, during which the study procedures will be explained in detail and any questions addressed. Individuals who agree to participate will provide written informed consent and will be randomly allocated to one of the four intervention groups. All necessary study materials will be provided at this stage.
Participants will attend three scheduled clinical investigation visits: baseline (day 0), mid-intervention (week 8), and post-intervention (week 12). At each visit, anthropometric and body composition measurements will be performed, and blood pressure will be recorded. Biological samples, including blood, urine, and stool, will be collected. In addition, data regarding dietary intake, physical activity levels, sleep patterns, and gastrointestinal symptoms will be obtained through validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers of both sexes between the ages of 18 and 65 years old.
- •Volunteers with grade II overweight or obesity (BMI: 27.0-39.9 kg/m2).
- •Physical examination and vital signs are normal or clinically irrelevant to the study.
- •Volunteers receiving pharmacological treatment may be included if the dosage has remained stable for at least three months prior to study initiation.
- •Individuals undergoing treatment for diabetes will be excluded.
- •Participants must be capable of understanding the study requirements, willing to provide written informed consent, and able to comply with all study procedures and timelines.
- •Body weight must have remained stable (±5%) during the three months preceding study initiation.
排除标准
- •Presence of significant functional or structural abnormalities of the digestive system, including but not limited to congenital malformations, angiodysplasia, active peptic ulcer disease, chronic inflammatory or malabsorption disorders, hiatal hernia, or chronic gastroesophageal reflux.
- •High alcohol consumption, defined as >14 units per week for women and >20 units per week for men.
- •Pregnancy or lactation at the time of screening.
- •History of surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or joint replacement surgery (hip or knee).
- •Diagnosis of arthritis.
- •History of any liver disease, with the exception of non-alcoholic fatty liver disease.
- •Diagnosis of any type of cancer, current cancer treatment, or history of cancer treatment within the past five years.
- •Known allergy or hypersensitivity to any component of the investigational product or to any food that could interfere with study participation and follow-up.
- •Presence of cognitive and/or psychological impairment that could affect study compliance.
- •Anticipated poor adherence or, in the opinion of the investigator, inability to comply with study procedures.
- •Engagement in night-shift work.
- •Current use of dietary supplements that may interfere with study outcomes (e.g., nutraceuticals containing compounds with potential weight loss effects).
- •Ongoing treatment for weight loss or diabetes.
研究组 & 干预措施
Experimental group 1
Experimental
Bars containing satiating compounds: formulation 1
干预措施: Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction) (Dietary Supplement)
Experimental group 2
Experimental
Bars containing satiating compounds: formulation 2
干预措施: Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction) (Dietary Supplement)
Experimental group 3
Experimental
Bars containing satiating compounds: formulation 3
干预措施: Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction) (Dietary Supplement)
Placebo group
Placebo Comparator
Placebo bars
干预措施: Placebo Bar + Hypocaloric diet (10% energy restriction) (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Weight of participants will be measured by bioimpedance an densitometry and reported in kg
次要结局
- Insulin concentration(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Triglyceride concentration(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Plasma CTX-II levels (C-terminal telopeptide of type II collagen)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Waist circumference(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Neck circumference(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Fat free mass(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.)
- Body bone mass(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Heart rate(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Total bone mineral density(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Want to eat something else(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Thirst(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Life quality(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Depression(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Hydroxyproline(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Anxiety(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Osteoarticular health(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Physical activity(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Gastrointestinal symptoms(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Glucose concentration(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- HOMA index (Homeostatic Model Assessment Index)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Total cholesterol(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- HDL cholesterol(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- LDL cholesterol(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Alanine aminotransferase(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Aspartate aminotransferase(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Gamma-glutamyl transferase(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Fatty liver Index (FLI)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Fructosamine concentration(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Leptine(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Adiponectin(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Homocysteine(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- MCP1 (Monocyte Chemoattractant Protein-1)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- TNF-alpha (tumor necrosis factor alpha)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Blood glycated hemoglobin(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Interleukin 6 (IL6)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- C Reactive protein (CRP)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Plasma C2C levels (Cartilage Collagen Neoepitope)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.)
- Plasma CP2 levels (type II procollagen carboxy-propeptide)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.)
- Albumin concentration(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Creatinine concentration(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Blood untargeted metabolomics(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Urine untargeted metabolomics(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Lipidomic(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Dietary Intake (Energy and Nutrients)(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Mediterranean Diet Adherence(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Snacking frequency(Clinical Investigation Day 1, Clinical Investigation Day 2, and Clinical Investigation Day 3)
- Height(Clinical Investigation Day 1)
- Body mass index(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Hip circumference(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Body fat mass(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Body lean mass(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Body muscle mass(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Visceral fat(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Body water mass(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Adherence to bars consumption(Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Acceptance of bars(Clinical Investigation Day 3)
- Systolic blood pressure(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Diastolic blood pressure(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3)
- Bone mineral density L1-L4(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.)
- Total bone mineral density femur(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.)
- Bone mineral density femur neck(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.)
- Knee articular range(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.)
- Grip strength(Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.)
- Level of hunger(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Level of fullness(Clinical Investigation Day 1, Clinical Investigation Day 2)
- Level of satisfaction(Clinical Investigation Day 1, Clinical Investigation Day 2)
研究者
研究点 (1)
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