A Randomised, Double-blinded, Placebo- Controlled, Parallel Study, to Assess the Effect of a Whole Fruit Powder on Gut Microbiome Function on Overweight & Obese Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effect of freeze-dried blueberry powder on the gut microbiome.
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of freeze-dried blueberry powder on the gut microbiome in overweight and obese adults. The main question[s] it aims to answer are:
- Does the supplementation of freeze-dried blueberry powder reduce the risk of obesity or lower the weight of people with a high BMI?
- Does freeze-dried blueberry powder alter the gut microbiome function? Participants will;
- Mix one sachet of Study Product (freeze-dried blueberry powder/placebo) into breakfast/dessert/yoghurt daily for 56 days during the intervention phase.
- Partake in 4 site visits over the 14-week period, including an initial screening visit and a follow-up visit after the intervention phase.
Researchers will compare the effect of freeze-dried blueberry powder with a placebo in a population comprising overweight and obese adults to see if the gut microbiome is altered and if there is a change in body composition.
详细描述
Definition: Extended description of the protocol, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures. For Patient Registries: Also describe the applicable registry procedures and other quality factors (for example, third party certification, on-site audit). In particular, summarize any procedures implemented as part of the patient registry, including, but not limited to the following:
- Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
- Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
- Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (for example, medical records, paper or electronic case report forms, or interactive voice response systems).
- Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used (for example, World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant.
- Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
- Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
- Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results.
- Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
Randomised, double-blinded, placebo-controlled, parallel study in overweight and obese adults.
- Screening phase: 14 days
- Intervention phase: 56 days
- Follow-up phase: 28 days
Participants will be provided with an 8-week supply of product (60 sachets) at Visit 2 and instructed to consume one sachet per day for eight-weeks. Participants will be recruited via an initial pre-screening questionnaire.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blinding of both study team and Participants will be ensured by only providing access to the randomisation list to the science and quality team which is stored in the quality drive. The relationship between the randomisation number and the group assignment will be unknown to the Participants, clinical study team, and the Sponsor, i.e., the study will be double-blinded.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to give written informed consent.
- •Adults between 50 to 65 years inclusive.
- •Has a BMI > 27 kg/m
- •Low fibre diet, <18 g/day.
- •Is in general good health, as determined by the investigator.
- •Willing to consume the Study Product daily for the duration of the study.
排除标准
- •Participants who are pregnant or wish to become pregnant during the study, or who are currently breastfeeding.
- •Participants currently of childbearing potential, but not using continuous effective method of contraception.
- •Metabolic disease including diabetes.
- •Participants has acute or chronic gastrointestinal and/or infective disease (i.e., coeliac disease, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.), or with a history of such diseases.
- •Have a significant acute or chronic coexisting illness such as uncontrolled hypertension, uncontrolled hyperlipidaemia, hypercoagulation, inflammatory disorders, or any condition which contraindicates, in the investigator's judgement, entry to the study.
- •Smoking more than 5 cigarettes per day.
- •Participant has a history of drug and/or alcohol abuse at the time of enrolment (Drinks more than nationally recommended units per week (>11 units for women; >17 units for men); alcohol/substance abuse disorder).
- •Reported change in diet 30 days prior to Visit
- •Participants who have taken oral antibiotics 12 weeks prior to visit
- •Change in supplements, or major changes in lifestyle (i.e., diet, dieting, exercise level, travelling) for duration of the study.
- •Has a malignant disease or any concomitant end-stage organ disease, and are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, or chemotherapy or radiotherapy which, in the Investigator's judgment, contraindicates participation in the study.
- •Is hypersensitive to any of the components of the Study Product.
- •Has received treatment involving experimental drugs in the past 90 days and experimental supplements in the past 30 days at the discretion of the investigator.
- •Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their immediate family member or a member of their household.
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
研究组 & 干预措施
Freeze-dried Blueberries
Participants will be provided with an 8-week supply of study product (freeze-dried blueberry) to be consumed daily.
干预措施: Freeze-dried blueberries (Dietary Supplement)
Maltodextrin, Glucose, Fructose and Sucrose Placebo
Participants will be provided with an 8-week supply of placebo product (maltodextrin, glucose 31%, fructose 30%, sucrose 0%; produced as a purple powder, with blueberry aromatics generated from natural (non-anthocyanin) and artificial colour and flavourings) to be consumed daily.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Effect of freeze-dried blueberry powder on the gut microbiome.
时间窗: 8 weeks
To evaluate the effect of freeze-dried blueberry powder compared to placebo, in a population comprising of overweight and obese adults on: \- Alteration of gut microbiome function and gene count Change in gut microbiome function and gene count, as measured by shotgun metagenomics from baseline (Week 0) to end of intervention (Week 8).
Effect of freeze-dried blueberry powder on the gut permeability
时间窗: 8 weeks
To evaluate the effect of freeze-dried blueberry powder compared to placebo, in a population comprising of overweight and obese adults on: \- Gut permeability Change in gut permeability, as measured from lactulose/mannitol ratio from baseline (Week 0) to end of intervention (Week 8).
次要结局
- Effect of freeze-dried blueberry powder on lipid profile in a population of overweight and obese adults(8 weeks)
- Effect of freeze-dried blueberry powder on body composition in a population of overweight and obese adults(8 weeks)
- Effect of freeze-dried blueberry powder on serum metabolites in a population of overweight and obese adults(8 weeks)
- Effect of freeze-dried blueberry powder on faecal bile acid metabolites in a population of overweight and obese adults(8 weeks)
- Effect of freeze-dried blueberry powder on polyphenol metabolites in a population of overweight and obese adults(8 weeks)
- Effect of freeze-dried blueberry powder on urine and faecal metabolites in a population of overweight and obese adults(8 weeks)