An Open-Label, Randomised, Crossover Study to Investigate the Feasibility of Nitrate Fortification in Commonly Consumed Foods for Regulating Nitric Oxide Metabolism in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To investigate and compare the changes of NO3- and NO2- concentrations in plasma following the ingestion of three different NO3--fortified foodstuffs: cereal bar, porridge, and biscuits.
研究概览
简要总结
Inorganic nitrate, found in leafy green vegetables and beetroot, can help lower blood pressure and support heart health. Early experimental work has suggested that dietary nitrate supplementation, in the form of beetroot juice or potassium nitrate capsules, can reduce blood pressure and improve endothelial function. Consequently, concentrated nitrate supplements like beetroot juice have become popular. However, these supplements can be expensive, high in sugar, and not to everyone's taste. Since more than three-quarters of adults with high blood pressure live in low- and middle-income countries, it is important to find safe, affordable ways to add nitrate to commonly eaten foods.
The team at Queen Mary University of London has been developing nitrate-fortified products that may be more appealing to a wider population. With support from the food manufacturer Reading Scientific Services Ltd. (RSSL), they have successfully added nitrate to three oat-based products: cereal bar, porridge, and biscuits.
This study aims to explore whether adding nitrate to commonly eaten foods can improve nitric oxide levels in the body and help lower blood pressure in healthy volunteers. Participants will receive the three nitrate-fortified food products in a randomised, crossover design. Nitrate and nitrite concentrations in biological samples, along with blood pressure, will be measured before and at multiple time points after supplementation with the nitrate-fortified products.
详细描述
Whether adding nitrate to commonly eaten foods can improve nitric oxide levels in the body and help lower blood pressure in healthy volunteers will be investigated.
Design: An open-label, randomised, crossover trial. Target population: Thirty healthy participants (15 males and 15 females) will be recruited.
Experimental intervention: Equal numbers of healthy male and female volunteers, aged 18-60 years, will be recruited. Following recruitment, participants will attend the clinical centre on seven occasions. At baseline, clinic blood pressure will be measured, and plasma, urine, and saliva samples will be collected. Participants will then receive one of the three nitrate-fortified food products according to the randomisation plan.
Clinic blood pressure will be measured at 1, 2, 3, and 4 hours post-supplementation. Blood samples will be collected at 0.5, 1, 1.5, 2, 2.5, 3, and 4 hours; urine at 4 hours; and saliva at 3 and 4 hours. At 24 hours post-supplementation, participants will return to the clinical centre for repeat blood pressure measurement and collection of blood, urine, and saliva samples. All human biological samples will be stored for subsequent determination of nitrate and nitrite concentrations.
If participants receive nitrate-fortified biscuits during one visit, they will be given either nitrate-fortified porridge or a cereal bar at the following visits, according to the randomisation plan. All participants will eventually receive all three nitrate-fortified food products, each providing approximately 4 mmol nitrate, an amount within the Acceptable Daily Intake (ADI) range.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer.
- •Aged ≥18 years and ≤ 60 years.
- •Willing to provide informed consent.
- •Able to understand and comply with protocol requirements, instructions, and stated restrictions.
排除标准
- •A volunteer will not be eligible for inclusion in this study if any of the following criteria are met:
- •Unwilling to provide consent.
- •People with chronic health conditions requiring medication.
- •Pregnant females, or those with a possibility of being pregnant.
- •History of hypertension and /or diabetes.
- •History of any serious illnesses, including recent infections or trauma.
- •History of symptomatic coronary artery disease, stroke, or other known atherosclerotic diseases.
- •People who will commence or who are likely to commence treatment with non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin, from screening until study completion.
- •Self-declared alcohol or drug abuse within the past 6 months.
- •Three-month prior history of regular alcohol consumption exceeding an average weekly intake of > 28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of > 21 units (or an average daily intake of greater than 2 units) for females. One unit is equivalent to a half pint (284mL) of beer/lager; 25mL of spirits, or 125mL of wine.
- •Taking systemic medication (other than the oral contraceptive pill).
- •Recent (within 2 weeks) self-reported use of mouthwash or tongue scrapers.
- •Recent (within 2 weeks) or current antibiotic use.
- •Recent (within 1 week) use of NO3- or NO2- supplements.
- •History, or recent treatment of (within the last 3 months) for any oral condition (excluding caries), including gingivitis, periodontitis and halitosis.
- •History of, or recent treatment for, any blood-borne infectious disease such Hepatitis B or C virus, or HIV.
- •Current smokers (including vaping) or have smoked within the last 6 months.
- •Diagnosis of rheumatoid arthritis, connective tissue disorders, and other conditions known to be associated with chronic inflammation (e.g., Inflammatory Bowel Disease).
- •People who have donated more than 500mL of blood within 56 days prior to the study commencement.
- •Known allergy to celery, gluten, crustaceans, eggs, lupin, milk, mustard, peanuts, sesame, soybeans, tree nuts, oats, palm oil, sugar, cranberries, sunflower oil, invert syrup, sodium bicarbonate.
研究组 & 干预措施
Arm 1: Nitrate-fortified biscuits (NFB)
Biscuits were fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range.
干预措施: Inorganic potassium nitrate-fortified biscuits supplementation (Dietary Supplement)
Arm 2: Nitrate-fortified cereal bar (NFCB)
A cereal bar was fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range.
干预措施: Inorganic potassium nitrate-fortified cereal bar supplementation (Dietary Supplement)
Arm 3: Nitrate-fortified porridge (NFP)
Porridge was fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range.
干预措施: Inorganic potassium nitrate-fortified porridge supplementation (Dietary Supplement)
结局指标
主要结局
To investigate and compare the changes of NO3- and NO2- concentrations in plasma following the ingestion of three different NO3--fortified foodstuffs: cereal bar, porridge, and biscuits.
时间窗: Up to 1 year
Mean Plasma NO3- and NO2- concentrations at baseline, 0.5-, 1-, 1.5-, 2-, 2.5-, 3-, 4-, and 24-hours post-ingestion of the three NO3--fortified foodstuffs as well as area under the curve (AUC) across the 24 hours.
次要结局
- To investigate and compare the changes of NO3- and NO2- concentrations in other human biological samples, such as saliva and urine, following the ingestion of the three different NO3--fortified foodstuffs.(Up to 1 year.)
- To investigate and compare the changes in cGMP concentration in plasma following the ingestion of the three different NO3--fortified foodstuffs.(Up to 1 year.)
- To assess participants' acceptability of the three different NO3--fortified food products.(Final laboratory visit (assessed at this time).)
- To investigate and compare the blood pressure-lowering effects of the three different NO3--fortified foodstuffs.(Up to 6 months.)