- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07665944
Hydroponic vs Conventional Spinach Smoothies: Effects on Salivary Nitrate Bioavailability and Blood Pressure (SPIN-BP-NO)
Acute Effects of Hydroponically vs. Conventionally Grown Spinach Smoothies on Salivary Nitrate Bioavailability and Blood Pressure: A Randomized Controlled Crossover Trial
The goal of this clinical trial is to determine whether hydroponic spinach (HS) versus conventional spinach (CS) smoothies produce differential post-consumption effects on salivary nitrate availability and blood pressure in adults.
The main questions it aims to answer are:
Do hydroponic spinach (HS) and conventional spinach (CS) smoothies produce differential post-consumption salivary nitrate availability responses in adults when consumed in equal volumes? Do hydroponic spinach (HS) and conventional spinach (CS) smoothies produce differential post-consumption blood pressure responses in adults when consumed in equal volumes?
Participants will:
Consume hydroponic spinach (HS) and conventional spinach (CS) smoothies on two separate study days.
Attend two laboratory visits at the university, scheduled within a 1-2 week period.
Undergo check-ups and study measurements during each visit (e.g., blood pressure and saliva sampling).
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
This randomized, double-blind, crossover study will investigate the acute effects of hydroponic spinach (HS) compared with conventional spinach (CS) smoothies on vascular responses in adults. The study aims to determine whether HS and CS smoothies elicit differential effects on nitrate bioavailability and blood pressure.
Spinach is a rich source of dietary nitrate, which can be converted via the enterosalivary pathway to nitrite and subsequently to nitric oxide, a key regulator of vascular function and blood pressure. The nitrate content of spinach varies according to cultivation methods, with hydroponically grown spinach often reported to have higher nitrate concentrations than conventionally grown spinach. However, it remains unclear whether these compositional differences translate into meaningful physiological effects following consumption.
Participants will attend two laboratory visits separated by a washout period of approximately 7-14 days. In this randomized crossover design, each participant will receive both interventions in a randomized order, enabling within-subject comparisons. At each visit, participants will consume a standardized smoothie containing either hydroponic or conventional spinach. The smoothies will be matched for volume and appearance to maintain blinding of both participants and investigators.
Baseline measurements will be obtained prior to smoothie consumption. Following intake, measurements will be repeated over the acute postprandial period, including at 2 hours post-consumption, to assess physiological responses. These assessments will include saliva samples to evaluate nitrate bioavailability (salivary nitrate) and cardiovascular measures-systolic blood pressure, diastolic blood pressure, mean arterial pressure (MAP), and heart rate (HR).
The crossover design allows each participant to act as their own control, thereby reducing inter-individual variability and improving statistical power in this pilot investigation.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Raul Bescos, PhD
- Puhelinnumero: +44 1752 587585
- Sähköposti: raul.bescos@plymouth.ac.uk
Tutki yhteystietojen varmuuskopiointi
- Nimi: Patricia Casas Agustench, PhD
- Puhelinnumero: +44 1752 588892
- Sähköposti: patricia.casas@plymouth.ac.uk
Opiskelupaikat
-
-
Devon
-
Plymouth, Devon, Yhdistynyt kuningaskunta, PL4 6AB
- Rekrytointi
- University of Plymouth
-
Ottaa yhteyttä:
- Raul Bescos, PhD
- Puhelinnumero: +44 1752 587585
- Sähköposti: raul.bescos@plymouth.ac.uk
-
Ottaa yhteyttä:
- Patricia Casas Agustench, PhD
- Puhelinnumero: +44 1752 588892
- Sähköposti: patricia.casas@plymouth.ac.uk
-
Päätutkija:
- Raul Bescos, PhD
-
Päätutkija:
- Patricia Casas Agustench, PhD
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Adults aged 18-60 years
- Generally healthy individuals (no diagnosed chronic disease)
- Non-smokers and non-vapers
- Not currently taking medications known to affect cardiovascular function or nitrate metabolism
- Able and willing to provide informed consent
- Willing to comply with study procedures and attend both study visits
Exclusion Criteria:
- Presence of chronic disease (e.g., cardiovascular, metabolic, renal, or respiratory conditions)
- Use of pacemakers or implanted medical devices
- Pregnant or lactating individuals
- Known allergy or intolerance to spinach
- History of gastrointestinal disorders or pathology affecting digestion or absorption
- Use of nitrate or nitrite supplements
- Use of antibiotics within the past 3 weeks
- Use of antibacterial mouthwash or oral products within the past 2 weeks
- Current participation in another clinical trial or recent participation that may interfere with outcomes
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Hydroponic then Conventional Spinach
Participants consume a hydroponic spinach smoothie at the first visit followed by a conventional spinach smoothie at the second visit, separated by a washout period.
|
Standardized smoothie prepared with hydroponically grown spinach, matched for volume and appearance.
Standardized smoothie prepared with conventionally grown spinach, matched for volume and appearance.
|
|
Kokeellinen: Conventional then Hydroponic Spinach
Participants consume a conventional spinach smoothie at the first visit followed by a hydroponic spinach smoothie at the second visit, separated by a washout period.
|
Standardized smoothie prepared with hydroponically grown spinach, matched for volume and appearance.
Standardized smoothie prepared with conventionally grown spinach, matched for volume and appearance.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Salivary nitrate concentration
Aikaikkuna: Baseline and 2 hours post-consumption
|
Salivary nitrate levels assessed at baseline and 2 hours post-consumption as a marker of nitrate bioavailability.
|
Baseline and 2 hours post-consumption
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Systolic blood pressure
Aikaikkuna: Baseline and 2 hours post-consumption
|
Systolic blood pressure measured at baseline and 2 hours after consumption of hydroponic and conventional spinach smoothies.
|
Baseline and 2 hours post-consumption
|
|
Diastolic blood pressure
Aikaikkuna: Baseline and 2 hours post-consumption
|
Diastolic blood pressure measured at baseline and 2 hours after consumption of hydroponic and conventional spinach smoothies.
|
Baseline and 2 hours post-consumption
|
|
Mean arterial pressure
Aikaikkuna: Baseline and 2 hours post-consumption
|
Mean arterial pressure measured at baseline and 2 hours post-consumption.
|
Baseline and 2 hours post-consumption
|
|
Heart rate
Aikaikkuna: Baseline and 2 hours post-consumption
|
Heart rate measured at baseline and 2 hours post-consumption.
|
Baseline and 2 hours post-consumption
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Blekkenhorst LC, Bondonno NP, Liu AH, Ward NC, Prince RL, Lewis JR, Devine A, Croft KD, Hodgson JM, Bondonno CP. Nitrate, the oral microbiome, and cardiovascular health: a systematic literature review of human and animal studies. Am J Clin Nutr. 2018 Apr 1;107(4):504-522. doi: 10.1093/ajcn/nqx046.
- Qadir OK, Seal CJ, Ashor AW, Tassotti M, Mena P, Del Rio D, Siervo M, Brandt K. Double-blind controlled dietary cross-over intervention with differentially fertilised intact lettuce leaves shows acute reduction in blood pressure in young adults, associated with faster uptake of nitrate than of phenolics. Eur J Nutr. 2022 Dec;61(8):4191-4203. doi: 10.1007/s00394-022-02961-5. Epub 2022 Jul 23.
- Jackson JK, Patterson AJ, MacDonald-Wicks LK, Oldmeadow C, McEvoy MA. The role of inorganic nitrate and nitrite in cardiovascular disease risk factors: a systematic review and meta-analysis of human evidence. Nutr Rev. 2018 May 1;76(5):348-371. doi: 10.1093/nutrit/nuy005.
- Hosseini MJ, Dezhangah S, Esmi F, S Gharavi-Nakhjavani M, Hashempour-Baltork F, Mirza Alizadeh A. A worldwide systematic review, meta-analysis and meta-regression of nitrate and nitrite in vegetables and fruits. Ecotoxicol Environ Saf. 2023 Jun 1;257:114934. doi: 10.1016/j.ecoenv.2023.114934. Epub 2023 Apr 19.
- Bryan NS, Ahmed S, Lefer DJ, Hord N, von Schwarz ER. Dietary nitrate biochemistry and physiology. An update on clinical benefits and mechanisms of action. Nitric Oxide. 2023 Mar 1;132:1-7. doi: 10.1016/j.niox.2023.01.003. Epub 2023 Jan 20.
- Bian Z, Wang Y, Zhang X, Li T, Grundy S, Yang Q, Cheng R. A Review of Environment Effects on Nitrate Accumulation in Leafy Vegetables Grown in Controlled Environments. Foods. 2020 Jun 3;9(6):732. doi: 10.3390/foods9060732.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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Avainsanat
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