- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02146157
Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
12. oktober 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.
Studietype
Intervensjonell
Registrering (Faktiske)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60610
- Radiant Research
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Kentucky
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Lexington, Kentucky, Forente stater, 40509
- Central Kentucky Research Associates
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Michigan
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Bingham Farms, Michigan, Forente stater, 48025
- Quest Research Institute
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Ohio
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Cincinnati, Ohio, Forente stater, 45249
- Radiant Research
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Dayton, Ohio, Forente stater, 45439
- Providence Health Partners Center for Clinical Research
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South Carolina
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Greer, South Carolina, Forente stater, 29651
- Mountain View Clinical Research
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change from Baseline in fasting blood glucose
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from Baseline in fasting serum glucose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 84
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Day 84
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
1. juni 2015
Studiet fullført (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først innsendt
7. april 2014
Først innsendt som oppfylte QC-kriteriene
20. mai 2014
Først lagt ut (Anslag)
23. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. oktober 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. oktober 2015
Sist bekreftet
1. oktober 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2012110
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