Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
12 octobre 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.
Type d'étude
Interventionnel
Inscription (Réel)
104
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60610
- Radiant Research
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40509
- Central Kentucky Research Associates
-
-
Michigan
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Bingham Farms, Michigan, États-Unis, 48025
- Quest Research Institute
-
-
Ohio
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Cincinnati, Ohio, États-Unis, 45249
- Radiant Research
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Dayton, Ohio, États-Unis, 45439
- Providence Health Partners Center for Clinical Research
-
-
South Carolina
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Greer, South Carolina, États-Unis, 29651
- Mountain View Clinical Research
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
herb and mineral product containing cinnamon, turmeric and holy basil
|
|
Comparateur placebo: placebo
Subjects will consume 3 softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period
|
Placebo of herb and mineral product containing cinnamon, turmeric and holy basil
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in fasting blood glucose
Délai: Day 84
|
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84
|
Day 84
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in fasting serum glucose
Délai: Day 42
|
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 42
|
Day 42
|
|
Change from Baseline in fasting blood glucose
Délai: Day 21
|
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 21
|
Day 21
|
|
Change from Baseline in HbA1c
Délai: Day 84
|
Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84.
|
Day 84
|
|
Change from Baseline in fasting lipids
Délai: Day 84
|
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.
|
Day 84
|
|
Change from Baseline in fasting lipids
Délai: Day 42
|
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.
|
Day 42
|
|
Change from Baseline in fasting lipids
Délai: Day 21
|
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.
|
Day 21
|
|
Change from Baseline in BMI
Délai: Day 84
|
Body mass index
|
Day 84
|
|
Change from Baseline in waist-to-hip ratio
Délai: Day 84
|
Day 84
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2013
Achèvement primaire (Réel)
1 juin 2015
Achèvement de l'étude (Réel)
1 juin 2015
Dates d'inscription aux études
Première soumission
7 avril 2014
Première soumission répondant aux critères de contrôle qualité
20 mai 2014
Première publication (Estimation)
23 mai 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 octobre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 octobre 2015
Dernière vérification
1 octobre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2012110
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