Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
12. Oktober 2015 aktualisiert von: NewChapter, Inc.
A Randomized, Double-blind, Placebo-controlled Trial to Assess Efficacy and Tolerability of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
This is a multi-center, randomized, double-blind, placebo-controlled study in approximately 104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination product on fasting serum glucose levels in subjects with impaired fasting glucose.
The study consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible subjects will be randomized to product to consume throughout the 12-week supplementation period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
104
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60610
- Radiant Research
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40509
- Central Kentucky Research Associates
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Michigan
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Bingham Farms, Michigan, Vereinigte Staaten, 48025
- Quest Research Institute
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45249
- Radiant Research
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Dayton, Ohio, Vereinigte Staaten, 45439
- Providence Health Partners Center for Clinical Research
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South Carolina
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Greer, South Carolina, Vereinigte Staaten, 29651
- Mountain View Clinical Research
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Be male or female, at least 18 years of age
- If age ≥45 years, must have a body mass index ≥ 25 kg/m2
- If age <45 years, must have a body mass index ≥ 25 kg/m2 AND present with at least one additional risk factors for developing diabetes.
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (women only)
- Be able to understand the nature and purpose of the study including potential risks and side effects
- Be willing to consent to study participation and to comply with study requirements
- Have a finger stick fasting blood glucose between 105 and 140 mg/dL and a serum fasting glucose between 100 and 125 mg/dL, measured at screening
Exclusion Criteria:
- Have diabetes (type I or II) or an HBA1c measurement >6.5% at any time in the past or at the screening visit
- Have been taking within 2 weeks of screening any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose metabolism
- Have been taking within 4 weeks of screening any prescription or over-the-counter (OTC) medication that significantly affects glucose metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, Inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors), systemic corticosteroids
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDS) (daily baby aspirin use and continuous use of NSAIDS for 3 days or less for acute aches and pains are acceptable)
- Any co-morbidity or treatment that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
- Anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction
- Eating disorder
- Polycystic ovary syndrome
- Known allergies or intolerance to any substance in the study product
- Are pregnant or breastfeeding women
- History of alcohol, drug, or medication abuse
- Have participated in another study with any investigational product within 1 month of screening
- Had a recent (<3 months) gastrointestinal surgery or any planned surgery during the clinical study
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: herb and mineral combination product
Subjects will consume 3 herb and mineral combination product softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period.
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herb and mineral product containing cinnamon, turmeric and holy basil
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Placebo-Komparator: placebo
Subjects will consume 3 softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period
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Placebo of herb and mineral product containing cinnamon, turmeric and holy basil
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change from Baseline in fasting blood glucose
Zeitfenster: Day 84
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Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84
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Day 84
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change from Baseline in fasting serum glucose
Zeitfenster: Day 42
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Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 42
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Day 42
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Change from Baseline in fasting blood glucose
Zeitfenster: Day 21
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Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 21
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Day 21
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Change from Baseline in HbA1c
Zeitfenster: Day 84
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Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84.
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Day 84
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Change from Baseline in fasting lipids
Zeitfenster: Day 84
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Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 84 using a standard lipid panel.
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Day 84
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Change from Baseline in fasting lipids
Zeitfenster: Day 42
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Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 42 using a standard lipid panel.
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Day 42
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Change from Baseline in fasting lipids
Zeitfenster: Day 21
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Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 21 using a standard lipid panel.
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Day 21
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Change from Baseline in BMI
Zeitfenster: Day 84
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Body mass index
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Day 84
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Change from Baseline in waist-to-hip ratio
Zeitfenster: Day 84
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Day 84
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2013
Primärer Abschluss (Tatsächlich)
1. Juni 2015
Studienabschluss (Tatsächlich)
1. Juni 2015
Studienanmeldedaten
Zuerst eingereicht
7. April 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Mai 2014
Zuerst gepostet (Schätzen)
23. Mai 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
14. Oktober 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Oktober 2015
Zuletzt verifiziert
1. Oktober 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2012110
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