NCT07229014招募中不适用
Effects of a Collagen Supplement on Quality of Life, Appetite and Glycaemic Control: a Randomised, Double-blinded, Placebo-controlled, Crossover Trial in Overweight and Obese Adults.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quality of life scores
研究概览
简要总结
This is a clinical trial aimed to investigate if a collagen supplement can improve quality of life, appetite and blood sugar in overweight and obese adults aged 18-65.
Hypothesis: Consumption of a collagen supplement for 8 days will improve quality of life and improve glycaemic control in comparison with a placebo in individuals overweight or with obesity with a perceived low quality of life.
Participants will be asked to:
- Consume a collagen peptide supplement for a total of 8 days at a time
- Fill in questionnaires about quality of life, appetite, mood and energy
- Wear continuous glucose monitors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, 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
- •Subject is a healthy (as assessed by medical history) male or female adult, aged 18-65 years and overweight or obese (BMI 25 - 40 kg/m2).
- •Subject has an impaired quality of life, as determined by scoring at least a total of 9 on the following questions:
- •In the past 4 weeks, did you feel you had a lot of energy? All of the time (1), most of the time (2), a good bit of the time (3), some of the time (4), a little of the time (5), and none of the time (6) (number 27 from SF-36 questionnaire) Version 3.0 [01/10/2025] Page 11 of 20
- •In the past 4 weeks, have you felt calm and peaceful? All of the time (1), most of the time (2), a good bit of the time (3), some of the time (4), a little of the time (5), and none of the time (6) (number 26 from SF-36 questionnaire)
- •In the past 2 weeks, did you have any difficulties with sleeping? Not at all (1), small amounts (2), moderate amounts (3), a great deal (4), an extreme amount (5), all the time (6) (number 3 from WHOQoL-100)
- •Participant has an email address, internet access, a compatible smartphone and is willing and able to maintain internet access throughout the trial to complete virtual visits via video conference and to engage with mobile apps to answer electronic questionnaires.
- •Subject is willing and able to comply with all study procedures, including consumption of the supplement daily, CGM use for 22 days total (2 x 11 days), complete standardised meal tests, and fill out health questionnaires.
- •Subject is willing to take a supplement of bovine animal origin.
- •Openness to participate in an online interview at the end of the study.
排除标准
- •Participant has a history or presence of uncontrolled and/or clinically important pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders.
- •Participant has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study product [e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the investigator), history of frequent diarrhoea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the investigator, medication managed reflux and/or clinically important lactose intolerance.
- •Participant has a history of chronic insomnia (defined as insomnia at least 3 d/week over the past month), a diagnosed sleep disorder (e.g., OSA), or a chronic medical condition that may impact energy/fatigue levels, in the judgment of the investigator.
- •Participant is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
- •Participant has a known allergy, intolerance, or sensitivity to any of the ingredients in the study product, including bovine animal products.
- •Participant has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- •Participant has experienced any major trauma or any other surgical event within three months of Virtual Visit
- •Participant has unstable use of a medication or supplement that the investigator considers may affect the outcomes of the trial.
- •Participant is currently in another biomedical research study or has been in the 30 days before screening.
- •Participant is an employee of, or has a financial interest in Darling Ingredients Inc.
- •The individual has a condition the investigator believes would interfere with his ability to provide informed consent and to comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.
- •Participant is a vegan or vegetarian or excludes bovine products for cultural or religious reasons.
研究组 & 干预措施
Collagen peptide then placebo
Experimental
2 x 5g of hydrolysed collagen peptide daily for 8 days then crossing over to the placebo
干预措施: Collagen peptide supplement (Dietary Supplement)
Collagen peptide then placebo
Experimental
2 x 5g of hydrolysed collagen peptide daily for 8 days then crossing over to the placebo
干预措施: Placebo (Other)
Placebo then collagen peptide
Experimental
2 x 5g of maltodextrin daily for 8 days then crossing over to the collagen peptide
干预措施: Collagen peptide supplement (Dietary Supplement)
Placebo then collagen peptide
Experimental
2 x 5g of maltodextrin daily for 8 days then crossing over to the collagen peptide
干预措施: Placebo (Other)
结局指标
主要结局
Quality of life scores
时间窗: Baseline and 8 days
Quality of life (QoL) scores based on the composite scoring of the 36-item Short Form Survey (SF-36)
次要结局
- Postprandial appetite, hunger, fullness, satiety or desire to eat(15, 30, 60, 120 and 180 minutes post-meal)
- Mood(Baseline and 7 days)
- Energy and fatigue(Baseline and 7 days)
- Sleep(Baseline and 8 days)
- Glycaemic variability(From baseline to 8 days)
- Postprandial glucose response(Continous monitoring up to 5 hours post-meal)
- Habitual diet(Baseline only)
研究者
研究点 (1)
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