- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT03155269
To Investigate the Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25- 45 Years) After 6 Months of Intervention
2019. január 15. frissítette: GlaxoSmithKline
Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25-45 Yrs; Inclusive) After 6 Months of Intervention: a Randomised Double Blind Controlled Trial
To investigate the effect of nutritional supplement on bone turnover markers (which are sensitive and respond quickly to nutrition or drug intervention) in Indian healthy premenopausal women after 6 months of intervention.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
This will be a double blind, single-center, randomized-controlled trial testing the effect of fortified beverage on bone turnover markers as compared to placebo control in 25-45 years old premenopausal women.
The study will consist of two groups: Group 1 (Test) - Protein rich beverage powder fortified with MMN and Group 2 (control) - Low protein non-fortified iso-caloric beverage powder.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
114
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
-
Pune, India, 411001
- GSK Investigational Site
-
-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
25 év (Felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Női
Leírás
Inclusion Criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Female Participants.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- BMI between 18.0-30 (kg/m2, Kilograms Per Meter Square) inclusive.
- Women who understand, willing, able and likely to comply with all study procedures and restrictions.
Exclusion Criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or Women who have a positive urine pregnancy test.
- Women who have attained physiological menopause defined as those who have not had a menstrual period for consecutive 12 months.
- Women who are breast-feeding.
- Current (within 14 days of the start of the study) or regular use of any prescription, over the counter (OTC), vitamin supplements herbal medicine unless the medication has been approved by the study physician.
- Treatment with bisphosphonates (any dose within the previous 2 years) or other medications known to affect bone (within the previous 6 months).
- History of metabolic bone disease.
- Any hormonal disorders or disturbances.
- Bone fracture in last 12 months.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participant is lactose intolerant.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last 1 year) of alcohol or other substance abuse.
- More than 2 Units of alcohol per day
- Smokers
- Currently taking any other health food drinks/beverages or supplements (including nutritional supplements e.g. multivitamins and/or herbal supplements e.g. ginkgo) or has been on supplements within a month prior to study start.
- Women who used medication known to influence bone mass and the use of calcium, vitamin D, and multivitamin supplements on a regular basis were stopped 2 months before the onset of the trial.
- An employee of the sponsor or the study site or members of their immediate family.
- Ongoing conditions known to cause abnormalities of calcium metabolism or skeletal health, malabsorption syndromes (such as coeliac or Crohn's disease), hyperthyroidism, hyperparathyroidism, hypo- or hypercalcaemia, osteomalacia, Paget's disease, and diabetes.
- Fracture in the past 12 months.
- Known chronic kidney disease or alcoholism.
- Obesity women ( Body Mass Index, BMI>30) and Thinness i.e. BMI<18 kg/m2
- Severely anemic (Hemoglobin, Hb<8 g/dl, Grams Per Decilitre).
- Undertaking excessive exercise (>2 strenuous* exercise sessions per week)
- Contraceptive injections within the previous year.
- Known histories of surgeries such as bilateral oophrectomy (surgical removal of ovaries)
- Diagnosed hypogondal states such as Turner syndrome, Klinfelter syndrome, Kallman
- syndrome, anorexia nervosa, hypothalamic amenorrhea or hyperprolactinemia
- Hemotological disorders e.g. Hemophilia, Leukemia and lymphomas monoclonal multiple myeloma, sickle cell disease, Thalassemia etc.
- Rheumatological and autoimmune disorders such as ankylosing spondylitis, rheumatoid arthritis, systemic lupus etc.
- Miscellaneous conditions and diseases such as Human Immunodeficiency Virus/acquired immunodeficiency syndrome (HIV/AIDS), alcoholism, amyloidosis, chronic metabolic acidosis, Chronic Obstructive Pulmonary Disease (COPD), congestive heart failure, depression etc.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Group 1- Protein rich beverage powder fortified with MMN
Participants will be administered orally two doses of cereal based fortified beverage (30 grams powder made up in 200 milliliter (mL) water) daily in the morning and evening for 6 months.
|
The tumbler will be filled with water up to the 200 mL mark.
The entire contents of one sachet (Fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps.
The reconstituted product will be consumed by the participants immediately orally.
|
|
Egyéb: Group 2 -Low protein non-fortified iso-caloric beverage powder
Participants will be administered orally two doses (in morning and evening) of low protein non fortified isocaloric beverage (30 grams powder made up in 200 mL water) daily for 6 months.
|
The tumbler will be filled with water up to the 200 mL mark.
The entire contents of one sachet (Non fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps.
The reconstituted product will be consumed by the participants immediately orally.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months
Időkeret: At baseline and at 6 months
|
s-CTX-1 is a bone resorption marker which is used to assess the bone health.
After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
CTX-1 serum was analysed using biochemical tests from the samples stored.
Decreased s-CTX-1 is associated with improved bone health.
|
At baseline and at 6 months
|
|
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months
Időkeret: At baseline and 6 months
|
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health.
After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored.
Increased c-OC/ uc-OC is associated with improved bone health.
|
At baseline and 6 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months
Időkeret: At baseline and at 3 months
|
s-CTX-1 is a bone resorption marker which is used to assess the bone health.
After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
CTX-1 serum was analysed using biochemical tests from the samples stored.
Decreased s-CTX-1 is associated with improved bone health.
|
At baseline and at 3 months
|
|
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months
Időkeret: At baseline and at 3 months
|
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health.
After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored.
Increased c-OC/ uc-OC is associated with improved bone health.
|
At baseline and at 3 months
|
|
Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months
Időkeret: At baseline, at 3 and 6 months
|
Urinary-CTX-1 is a bone resorption surrogate marker which is used to assess the bone health.
After 3 months and 6 months of taking the allocated product, spot urinary sample were collected.
CTX-1 urine levels were analysed using biochemical tests from the samples stored.
Decreased urinary CTX-1 is associated with improved bone health.
|
At baseline, at 3 and 6 months
|
|
Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
NTX-1 is a bone resorption surrogate marker which is used to assess the bone health.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
NTX-1 serum was analysed using biochemical tests from the samples stored.
Decreased s-NTX-1 is associated with improved bone health.
The unit of measurement is nanomole bone collagen equivalent (NM BCE).
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
P1NP is a bone formation surrogate marker which is used to assess the bone health being the most abundant protein of bone matrix.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
P1NP serum was analysed using biochemical tests from the samples stored.
Increased s-P1NP is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
BSAP is a bone formation surrogate marker which is used to assess the bone health.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
BSAP serum was analysed using biochemical tests from the samples stored.
Increased s-BSAP is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
PTH is used to compare calcium concentration status which defines the healthy bones.
Intact PTH is the biologically active form and is secreted when the calcium level is low.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
PTH serum was analysed using biochemical tests from the samples stored.
Decreased s-PTH is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Urinary Calcium at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Urinary calcium is used to compare calcium concentration status which defines the healthy bones.
After 3 months and 6 months of taking the allocated product, spot urinary sample were collected.
Urinary calcium was analysed using biochemical tests from the samples stored.
Decreased urinary calcium is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Serum Calcium at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Serum calcium is used to compare calcium concentration status which defines the healthy bones.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Serum calcium was analysed using biochemical tests from the samples stored.
Increased serum calcium is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Serum Phosphorus at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Serum phosphorus is a diagnostic marker for assessment of healthy bones.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Serum phosphorus was analysed using biochemical tests from the samples stored.
Increased serum phosphorus is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
ALP is a diagnostic marker of which is used to assess bone mineral density for assessment of healthy bones.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Serum ALP was analysed using biochemical tests from the samples stored.
Increased serum ALP is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Serum vitamin-D3 is used to analyse the status of vitamin-D profile which is necessary for healthy bones.
The marker used for analyzing serum vitamin-D3 was 25 OH D3.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Serum vitamin-D3 was analysed using biochemical tests from the samples stored.
Increased serum vitamin-D3 is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Serum Se is used to assess the status of micronutrient profile necessary for healthy bones.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Serum Se was analysed using biochemical tests from the samples stored.
Increased serum Se is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Plasma Zn is used to assess the status of micronutrient profile necessary for healthy bones.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Plasma Zn was analysed using biochemical tests from the samples stored.
Increased plasma Zn is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Serum folic acid (folate) is used to assess the status of micronutrient profile necessary for healthy bones.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Plasma Zn was analysed using biochemical tests from the samples stored.
Increased serum folate is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Plasma vitamin-B6 is used to assess the status of micronutrient profile necessary for healthy bones.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Plasma vitamin-B6 was analysed using biochemical tests from the samples stored.
Increased plasma vitamin-B6 is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
|
Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months
Időkeret: At baseline, at 3 months and 6 months
|
Serum vitamin-B12 is used to assess the status of micronutrient profile necessary for healthy bones.
After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition.
Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation.
Serum vitamin-B12 was analysed using biochemical tests from the samples stored.
Increased serum vitamin-B12 is associated with improved bone health.
|
At baseline, at 3 months and 6 months
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2017. május 25.
Elsődleges befejezés (Tényleges)
2018. január 16.
A tanulmány befejezése (Tényleges)
2018. január 16.
Tanulmányi regisztráció dátumai
Először benyújtva
2017. május 15.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2017. május 15.
Első közzététel (Tényleges)
2017. május 16.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2019. április 12.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2019. január 15.
Utolsó ellenőrzés
2019. január 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 207192
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Fortified Beverage Powder
-
ProofPilotQinaBefejezveIrritábilis bél szindróma | Irritábilis bél | IrritEgyesült Államok
-
Vectura LimitedUCB PharmaBefejezveAsztmaEgyesült Királyság
-
Anaiah Healthcare Pvt LtdThe Leeds Teaching Hospitals NHS Trust; Brighton and Sussex University Hospitals... és más munkatársakIsmeretlenGyermek táplálkozási zavarok | Gyermek alultápláltságEgyesült Királyság
-
NuBestCitruslabsBefejezveSúlygyarapodás | Kognitív funkció | MagasságEgyesült Államok
-
Chulalongkorn UniversitySanpasitthiprasong Hospital; Burapha UniversityBefejezve
-
HALEONBefejezveTáplálék-kiegészítőkEgyesült Államok
-
Mannkind CorporationBefejezve2-es típusú diabéteszEgyesült Államok, Orosz Föderáció, Brazília, Ukrajna
-
University of MichiganBefejezveParkinson kórEgyesült Államok
-
Masonic Cancer Center, University of MinnesotaVisszavont
-
BeamCitruslabsBefejezveAlvás | Alvászavar | AlváshigiéniaEgyesült Államok