- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00963118
Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability (Biogreen)
To achieve optimal health and to reduce the risk of age-related chronic diseases through an easily achievable dietary modification not achievable by the limited mixture of antioxidant supplements in older subjects, the investigators will focus their attention on the biological functions of bioactive plant food (Angelica keiskei and/or Glycine max) and its effect on genomic stability using noble assays.
The investigators propose to study the ability of bioactive plant-based food (Nutrition bar made from Angelica keiskei and/or Glycine max) to 1) exert biological functions: increase total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic stability: decrease DNA damage and modify DNA methylation. The investigators hypothesize that bioactive plant food (green leafy vegetable power, and/or black bean power) will exert biological functions and affect genomic stability far more efficiently than the limited mixture of purified antioxidant supplements in the vulnerable population, older subjects (> 50 years, men and postmenopausal women) with and without metabolic syndrome.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02111
- Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria: healthy control group (n=20)
- Age: over 50 years old
- Female subjects must be post-menopausal
- BMI: 18.5 - 30, waist/hip ratio < 0.9 for men, < 0.85 for women
- TG<150 mg/dL (1.7 mmol/L) and no medication for TG
- Total cholesterol < 200 mg /dL (5.18 mmol/L) and no medication for cholesterol
- Blood pressure: SBP < 130 mmHg and DBP < 85 mmHg and no hypertensive medication
- Plasma glucose: fasting blood glucose < 100 mg/dL (5.6 mmol/L) and no diabetes medication
Inclusion Criteria: Metabolic syndrome (n=40)
- Age: over 50 years old
- BMI: > 30 or waist/hip ratio > 0.9 for men, > 0.85 for women
Plus any two of the following four factors:
- TG: 150-400 mg/dL (1.7 - 4.52 mmol/L) and/or medication for TG
- HDL cholesterol: <40 mg /dL (1.03 mmol/L) for men, <50 mg/dL (1.29 mmol/L) for women and/or medication for cholesterol
- Blood pressure: SBP, 130-160 mmHg and/or DBP 85-95 mmHg and/or antihypertensive medication
- Plasma glucose: fasting blood glucose 100-125 mg/dL (5.55- 6.94 mmol/L) and no diabetes medication
Exclusion Criteria:
- Study participants will be screened for normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption.
- Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders will be excluded from the study.
- Exogenous hormone users will be excluded from the study.
- Moreover, subjects will be non-smokers and will not have taken vitamin or carotenoid supplements for at least 6 weeks prior to the study and throughout the study for both healthy subjects and subjects with metabolic syndrome.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: placebo
Rice powder based nutrition bar
|
Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
|
|
Experimental: Angelica keiskei
Angelica keiskei (green leafy vegetable) based nutrition bar
|
Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
|
|
Experimental: Glycine max
Glycine max (black soybeans) based nutrition bar
|
Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
|
|
Experimental: Angelica keiskei + Glycine max
Angelica keiskei (green leafy vegetable) and glycine max (black soybeans) based nutrition bar
|
Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
plasma total antioxidant performance, DNA damage and DNA methylation
Zeitfenster: baseline, 2 & 4 wks after supplementation
|
baseline, 2 & 4 wks after supplementation
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid)
Zeitfenster: Baseline, 2 & 4 wks after supplementation
|
Baseline, 2 & 4 wks after supplementation
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FRGN52
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .