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

NCT05298410 | Completed Phase 2

• 1 other identifier: 19LPHL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 baseline to Day 30 post-supplementation on several parameters of vascular function will be examined and safety outcomes will be determined.

Conditions

Hypertension

Keywords

NAD+ boosting investigational product; Mild hypertension; Limitless; Low carbohydrate diet

Outcome Measures

Primary Outcomes (6)

• Changes to blood pressure from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  Changes to blood pressure will be reported from baseline and compared to day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to forearm blood flow velocity from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  Changes to forearm blood flow will be reported from baseline and compared to day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to plasma L-arginine from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  Changes to plasma L-arginine will be reported from baseline and compared to day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to oral nitric oxide from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  Changes to oral nitric oxide will be reported from baseline and compared to day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to blood nitrate from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  Changes to blood nitrate will be reported from baseline and compared to day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to blood peroxynitrite levels from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  Changes to blood peroxynitrite levels will be reported from baseline and compared to day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

Secondary Outcomes (38)

• Changes to plasma nicotinamide from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to blood urea from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to C-reactive protein from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to homocysteine from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes to glutathione from baseline to Day 30 post-supplementation with Limitless in addition to a low carbohydrate diet

  30 days

Other Outcomes (29)

• Incidence of pre-emergent adverse events following 30-day supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Incidence of post-emergent adverse events following 30-day supplementation with Limitless in addition to a low carbohydrate diet

  30 days

• Changes in heart rate following 30-day supplementation with Limitless in addition to a low carbohydrate diet

  30 days

Study Arms (1)

Limitless

EXPERIMENTAL

Participants will be instructed to take Limitless capsules for 30 days starting with the first dose to be administered in clinic on Visit 2 (Day 1, Baseline). The last dose will occur in clinic on Visit 3 (Day 30). Participants will be instructed to take two capsules two hours with water after breakfast, and two capsules two hours after dinner. Do not take food after evening dose before bed. (i.e. no snacking or desserts.). If a dose is missed participants are instructed to skip that dose. Participants will be advised not to exceed four capsules daily.

Other: Limitless

Interventions

Limitless OTHER

Participants will be instructed to take Limitless for 30 days.

Limitless

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Limitless Research Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A5R8, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: March 17, 2022
• Primary Completion: September 28, 2022
• Study Completion: October 27, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

CA (1)