- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02678611
A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects. (15BSHE)
28. juli 2016 opdateret af: Elysium Health
A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
This study will investigate the safety, tolerability and potential health benefits of the dietary supplement, Basis.
There will be two doses of Basis compared to a placebo.
One third of subjects will receive the low dose Basis, one third will receive the higher dose Basis and one third will receive placebo.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
London, Ontario, Canada, N6A 5R8
- KGK Synergize Inc.
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Males or females 60 to 80 (inclusive) years of age
- Body Mass Index (BMI) must be 18 to 35 kg/ m2 (±1 kg/m2)
- •Be able to make scheduled office visits 4 times during the study
- Willing to follow the instructions and complete multiple study questionnaires and assessments
- Agrees to avoid taking Vitamin B3 (Niacin, Nicotinic acid or niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period
- Healthy otherwise as determined by laboratory results and medical history
- Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
- History of any significant chronic disease or any clinically active illness within 3 months of study entry, including any history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease. Clinical significance of disease will be assessed by the Qualified Investigator and eligibility determined.
- Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease
- Subjects with or who have recently experienced a traumatic injury, infections or undergone surgery
- Subjects with history of pellagra or niacin deficiency
- Taking lipid lowering drugs
- Use of natural health products containing Nicotinamide riboside within 14 days prior to randomization and during the course of the study
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Volunteers with cancer in full remission more than 5 years after diagnosis are acceptable
- Has participated in any clinical trial with an investigational medicinal product within the past three months prior to the first dose in the current study
- Unstable medical conditions
- Alcohol use >2 standard alcoholic drinks per day
- History of alcoholism or drug abuse within 1 year prior to screening
- History of significant allergies
- Allergy or sensitivity to any of the investigational product ingredients
- Use of medicinal marijuana
- Clinically significant abnormal laboratory results at screening
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
|
Eksperimentel: Basis 250
|
|
Eksperimentel: Basis 500
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood pressure
Tidsramme: 8 weeks
|
Assessment of blood pressure
|
8 weeks
|
Safety Blood Parameters
Tidsramme: 8 weeks
|
Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin)
|
8 weeks
|
Heart Rate
Tidsramme: 8 weeks
|
Assessment of heart rate
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blodtryk
Tidsramme: 8 uger
|
8 uger
|
|
Physiological Performance
Tidsramme: 8 weeks
|
6 Minute Walk Test
|
8 weeks
|
Physiological Performance
Tidsramme: 8 weeks
|
30 Second Chair Stand Test
|
8 weeks
|
Physiological Performance
Tidsramme: 8 weeks
|
Physical Activity Scale for the Elderly
|
8 weeks
|
Body Weight
Tidsramme: 8 weeks
|
8 weeks
|
|
Serum Glucose
Tidsramme: 8 weeks
|
8 weeks
|
|
Lipid Profile
Tidsramme: 8 weeks
|
8 weeks
|
|
Quality of Life and Sleep Quality
Tidsramme: 8 weeks
|
Health Assessment Questionnaire
|
8 weeks
|
Quality of Life and Sleep Quality
Tidsramme: 8 weeks
|
Older People's Quality of Life Questionnaires
|
8 weeks
|
Blood NAD+
Tidsramme: 8 weeks
|
8 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Expression Profile of Peripheral Blood Mononuclear Cells
Tidsramme: 8 weeks
|
8 weeks
|
|
Pain Assessment
Tidsramme: 8 weeks
|
VAS Pain Scale
|
8 weeks
|
Endothelial Function
Tidsramme: 8 weeks
|
EndoPat
|
8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2016
Primær færdiggørelse (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først indsendt
3. februar 2016
Først indsendt, der opfyldte QC-kriterier
9. februar 2016
Først opslået (Skøn)
10. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 15BSHE
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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