Status:
COMPLETED
The Safety and Efficacy of an NAD+ Boosting Product Together With a Low Carbohydrate Diet in Adults With Mild Hypertension and Eligible for Normal-standard-of-care
Lead Sponsor:
Limitless Research Inc.
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Hypertension
Eligibility:
All Genders
45-65 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and efficacy of Limitless, in combination with a low-carbohydrate diet, after 30 days of supplementation in an adult population. Changes from base...
Detailed Description
With an aging population, and the resulting economic and health burdens, strategies to support healthy aging and mitigate age-associated metabolic changes are essential. Recent studies have demonstra...
Eligibility Criteria
Inclusion
- Males and females between 45 and 65 years of age, inclusive
- BMI between 20.0-32.5 + 0.1 kg/m2, inclusive
- Waist circumference \< 102 cm (40 inches) in men and \< 88 cm (35 inches) in women
- Individuals with mild hypertension (seated resting systolic blood pressures between 120-150 mmHg (inclusive) and diastolic blood pressure ≤ 95 mmHg at screening) and eligible for normal-standard-of-care, as per QI.
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Ability to complete six-minute walk and treadmill VO2 max tests
- Agrees to adhere to dietary guidelines and to maintain current activity level throughout the study
- Agrees to avoid caffeine consumption 8-hours prior to in-clinic visits
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history, laboratory results, and EKG, as assessed by Qualified Investigator (QI)
Exclusion
- Women who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- Individuals who follow a vegetarian or vegan diet
- Current use of lipid lowering medications, antihypertensive medications or prescribed medications that may affect NO synthesis as assessed by QI
- Current use of over-the-counter medications and supplements containing the ingredients in the IP or derivatives unless willing to washout
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- Type I or Type II diabetes
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune-compromised
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
- Self-reported confirmation of blood/bleeding disorders
- Use of medical cannabinoid products
- Chronic use of cannabinoid products as assessed by QI on a case-by-case basis
- Use of tobacco products within 6 months of baseline as assessed by the QI
- Alcohol intake \>2 standard drinks per day
- Alcohol or drug abuse within the last 12 months
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies within 30 days of enrollment, as assessed by the QI
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition, including self-reported confirmation of medical or neuropsychological condition and/or cognitive impairment, that in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures, or pose significant risk to the participant
Key Trial Info
Start Date :
March 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05298410
Start Date
March 17 2022
End Date
October 27 2022
Last Update
December 14 2023
Active Locations (1)
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1
KGK Science Inc.
London, Ontario, Canada, N6A5R8