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Everycell's Effect on DNA Damage, Inflammation, and Stress

22 maja 2014 zaktualizowane przez: John E. Lewis, University of Miami

The Effect of Dietary Supplementation on DNA Damage, Inflammation, Stress, and Related Factors Important in Somatic and Stem Cell Senescence in Healthy Adults

The investigators are conducting this research because they want to determine if a dietary supplement, called Everycell™, has an effect on the functioning of the study participants' cells. The results of this research will be used to help develop additional strategies for trying to fight the effects of aging. The primary purpose of this study is to determine the effectiveness of Everycell™ compared to placebo (a pill that does nothing) on DNA damage, inflammation, stress, and related factors. Taking Everycell™ is not a medical prescription, treatment, or cure for any known disease or condition.

Helping patients' nutritional status is important to prevent the continued worsening of chronic diseases and also to counteract the effects of aging. Americans also have difficulties with compliance to prescription medications due to their toxicity and side effects. This study aims to learn more about how a dietary supplement may improve nutritional status and enable the body to normalize cellular functioning, which may improve quality of life. The results of this research will be used to determine if Everycell™ is beneficial for overall cellular health and to counteract the effects of aging.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The proposed study is a 6-week, randomized, double-blind, placebo-controlled trial to evaluate the effect of everycell compared to placebo on DNA damage, inflammation, stress, and related factors in 30 healthy adults (18-55 years of age). Participants will be assessed at baseline, 4 weeks (end of intervention), and 6 weeks (2-week washout period), and the study will consist of two treatment arms, including: (a) Everycell and (b) placebo. Additionally, the study will examine subject health-related quality of life (QoL).

Specific Aim. Test the effect of Everycell compared to placebo on DNA damage, inflammation, stress, and related factors in a sample of healthy adults.

Hypothesis. The Everycell group will demonstrate improvements in DNA damage, inflammation, stress, and related factors at 4 and 6-week follow-ups compared to placebo.

Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the IRB.

No substantial psychological, medical, or social risks exist to the participants, other than minor discomfort associated with the venipuncture. The components of everycell should be harmless without significant food allergies. No serious, untoward side effects have been reported to the company by consumers nor observed during previous human studies. If any side effect does occur, the remedy is to discontinue until asymptomatic, and then reintroduce at 1/4 dosage, increasing by the same amount every 2 days, if uneventful, until full dosage is achieved. A toxicology search for each component reveals no unique toxicity characteristic of the materials. As reported by CellHealth Institute, the manufacturer of the product, many customers currently use Everycell, and CellHealth Institute is unaware of significant toxicities.

CellHealth Institute applies the latest scientific methods to ensure the value and safety of their raw materials. CellHealth Institute products are manufactured in state-of-the-art facilities, under strict quality control and environmental protection standards.

Participants will incur no additional appreciable psychological or social risks by participating in this study, although they may undergo psychological and physical discomfort sometimes. The process of interviewing during the assessment may cause discomfort. Discomfort or fatigue may also be experienced in completing the assessment battery.

Alternatives to this study for improving DNA damage, inflammation, and stress include prescription medications, exercise, dietary modification, and other nutritional supplements. The risks of medications can be very significant, including life-threatening, but the risk of taking nutritional supplements is not totally understood, since they are not regulated by the US Food and Drug Administration. Medications and nutritional supplements, as part of a change in lifestyle behaviors, may also prove to be beneficial for DNA damage, inflammation, and stress, but their long-term use has unknown consequences.

The information obtained in this study will help in determining the efficacy of using a nutritional supplement for improving DNA damage, inflammation, and stress outcomes. By participating in the study, subjects may experience improved DNA damage, inflammation, and stress. The risk of participating in this study is reasonable because of the potential enhancements in DNA damage, inflammation, and stress with improved nutritional status.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Florida
      • Miami, Florida, Stany Zjednoczone, 33136
        • University of Miami Miller School of Medicine, Clinical Research Building

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 55 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Be between the ages of 18 and 55
  • Live independently without medical assistance
  • Willing to provide informed consent to participate in the study

  • Willing to follow our procedures and requirements for the study, including:

    1. providing blood, urine, and saliva samples
    2. completing other assessments
  • Patients may take a similar dietary supplement as the one used in the study, but they must stop taking all similar dietary supplements 2 weeks prior to starting the study and for the 6 weeks duration of the study.

Exclusion Criteria:

  • Patients need to be free of major medical conditions, such as neurological, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint disorders or conditions; psychiatric diagnoses or psychotic disorders, and have no gastrointestinal disorders that could affect how the dietary supplement is absorbed by their body.
  • Cannot participate in another similar research trial within 30 days of participating in this study
  • Cannot be a smoker or have stopped smoking less than 6 months ago
  • Cannot currently be taking any chemotherapy or radiation treatment for cancer
  • Cannot be diagnosed with a terminal illness
  • Cannot be diagnosed with insulin-dependent diabetes and/or be taking metformin
  • Cannot be HIV positive
  • If female, the patient cannot currently be pregnant, breastfeeding, or intending to become pregnant within the next month

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Everycell™
Patient will take 1 tablet two times daily of Everycell™ (double-blind) for the 4-week treatment period.
Suplement diety: Everycell™
Komparator placebo: Placebo
Patient will take 1 tablet two times daily of the placebo (double-blind) for the 4-week treatment period.
Inny: Placebo
Inne nazwy:
  • Pigułka cukrowa

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Nuclear factor kappa-light-chain-enhancer of activated B cells at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in Fructosamine at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in Protein Thiol Test at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in Homocysteine at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in Telomere Length at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in Cluster of Differentiation 4 (Regulatory T-cell) at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in Cluster of Differentiation 8 at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in Cluster of Differentiation 56 (Natural Killer cell) at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in 8-hydroxydeoxyguanosine at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Urine sample for 8-OHdG and 8-epi-PGF-2-alpha
Baseline, 4-week follow-up
Change from Baseline in 8-epi-PGF-2-alpha at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Urine sample for 8-OHdG and 8-epi-PGF-2-alpha
Baseline, 4-week follow-up
Change from Baseline in Forkhead box protein 3 (Regulatory T-cell) at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 4-week follow-up
Change from Baseline in Nuclear factor kappa-light-chain-enhancer of activated B cells at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in Fructosamine at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in Protein Thiol Test at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in Homocysteine at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in Telomere Length at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in Cluster of Differentiation 4 (Regulatory T-cell) at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in Cluster of Differentiation 8 at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in Cluster of Differentiation 56 (Natural Killer cell) at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in 8-hydroxydeoxyguanosine at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in 8-epi-PGF-2-alpha at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up
Change from Baseline in Forkhead box protein 3 (Regulatory T-cell) at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Baseline, 6-week follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Systolic Blood Pressure at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Systolic and diastolic blood pressure measured.
Baseline, 4-week follow-up
Change from Baseline in Pulse at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Baseline, 4-week follow-up
Change from Baseline in Waist Circumference at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Measure of body composition: waist circumference (cm).
Baseline, 4-week follow-up
Change from Baseline in Hip Circumference at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Measure of body composition: hip circumference (cm).
Baseline, 4-week follow-up
Change from Baseline in Weight at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Measure of body composition: weight.
Baseline, 4-week follow-up
Change from Baseline in Height at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Measure of body composition: height.
Baseline, 4-week follow-up
Change from Baseline in Body Mass Index at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Measure of body composition: height and weight to assess BMI.
Baseline, 4-week follow-up
Change from Baseline in International Physical Activity Questionnaire at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Baseline, 4-week follow-up
Change from Baseline in SF-36v2™ Health Survey at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Baseline, 4-week follow-up
Change from Baseline in Systolic Blood Pressure at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Systolic and diastolic blood pressure measured.
Baseline, 6-week follow-up
Change from Baseline in Diastolic Blood Pressure at 4 weeks
Ramy czasowe: Baseline, 4-week follow-up
Systolic and diastolic blood pressure measured.
Baseline, 4-week follow-up
Change from Baseline in Diastolic Blood Pressure at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Systolic and diastolic blood pressure measured.
Baseline, 6-week follow-up
Change from Baseline in Pulse at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Baseline, 6-week follow-up
Change from Baseline in Waist Circumference at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Measure of body composition: waist circumference (cm).
Baseline, 6-week follow-up
Change from Baseline in Hip Circumference at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Measure of body composition: hip circumference (cm).
Baseline, 6-week follow-up
Change from Baseline in Weight at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Measure of body composition: weight.
Baseline, 6-week follow-up
Change from Baseline in Height at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Measure of body composition: height.
Baseline, 6-week follow-up
Change from Baseline in Body Mass Index at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Measure of body composition: height and weight to assess BMI.
Baseline, 6-week follow-up
Change from Baseline in International Physical Activity Questionnaire at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Baseline, 6-week follow-up
Change from Baseline in SF-36v2™ Health Survey at 6 weeks
Ramy czasowe: Baseline, 6-week follow-up
Baseline, 6-week follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Miami

Współpracownicy

CellHealth Institute

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 2013

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2014

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2014

Daty rejestracji na studia

Pierwszy przesłany

2 stycznia 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 stycznia 2014

Pierwszy wysłany (Oszacować)

10 stycznia 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

23 maja 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 maja 2014

Ostatnia weryfikacja

1 maja 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20130411 (Inny identyfikator: Amgen Study ID)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Placebo

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Warunki medyczne

Interwencje lekowe

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Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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