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Nutritional Supplement for Healthy Adults

BR
Overseen ByBiofortis Research Clinical Director Biofortis Research Clinical Director

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a new proprietary nutritional supplement affects NAD+ levels in generally healthy adults. Participants will take either the experimental supplement or a placebo (a look-alike with no active ingredients) daily. Ideal candidates are aged 45-65, maintain a stable body weight, do not smoke or use nicotine, and are not on any weight loss plans. Participants should be prepared to follow study guidelines, including using a smartphone to track progress. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on nutritional supplements.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not have unstable use of any prescription medication or hormonal contraceptives. You also cannot use dietary supplements other than a daily multi-vitamin. If your current medications are stable and do not affect absorption, you may not need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the safety of dietary supplements, including the one under study, can vary. The FDA does not regulate these supplements as strictly as medications. Manufacturers must ensure their products are safe before selling them. However, the FDA can intervene if reports of serious issues arise.

For this specific supplement, past studies do not provide clear safety data. However, if manufactured carefully, safety data should exist for all its ingredients. Individuals can report any problems directly to the FDA.

While specific safety data for this new supplement is unavailable, dietary supplements are generally expected to be safe when used as directed. Consulting a healthcare provider before starting any new supplement is always advisable.12345

Why are researchers excited about this trial?

This proprietary nutritional supplement is unique because it offers a new approach to supporting overall health without relying on pharmaceuticals. Unlike standard supplements, which typically use isolated vitamins or minerals, this supplement combines a novel blend of nutrients designed to work synergistically, potentially enhancing absorption and effectiveness. Researchers are excited about its potential to deliver health benefits more efficiently and naturally, making it a promising option for those looking to maintain wellness in a more holistic way.

What evidence suggests that this proprietary nutritional supplement could be effective for healthy adults?

This trial will compare a proprietary nutritional supplement with a placebo supplement. Research has shown that dietary supplements can benefit health. One study found that people who took supplements felt 30% healthier than those who didn't. Another study discovered that taking supplements helped people gain weight and improve their nutrition. While not all supplements work the same way, they often help reduce problems like infections and support healing. Although results can differ, these studies suggest that supplements can help many adults stay healthier.678910

Who Is on the Research Team?

EB

Erin Barrett, PhD

Principal Investigator

Shaklee Corporation

Are You a Good Fit for This Trial?

This trial is for generally healthy men and women aged 45-65 with a BMI between 18.5 and 30, who can walk without help, use a smartphone, and are willing to follow study rules. People with certain medical conditions, recent surgeries, unstable medications, or using supplements (other than daily multivitamins) cannot join.

Inclusion Criteria

Willing to use personal smart phone with operating system (Android version 12.0 or newer; iOS version 16 or newer)
I can walk and have no injuries or conditions that limit my movement.
My BMI is between 18.5 and 30.
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Exclusion Criteria

I have recently started or changed my hormonal contraceptive or therapy.
History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator
Use of any dietary supplements (orally or infused), other than a conventional once daily multi-vitamin
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the proprietary nutritional supplement or placebo daily

8 weeks
Baseline, Day 30, Day 60

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo Supplement
  • Proprietary Nutritional Supplement

Trial Overview

The study compares the effects of a proprietary nutritional supplement versus a placebo on levels of NAD+ in healthy adults. Participants are randomly assigned to receive either the supplement or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Proprietary nutritional supplementExperimental Treatment1 Intervention
Group II: Placebo supplementPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shaklee Corporation

Lead Sponsor

Biofortis Clinical Research, Inc.

Industry Sponsor

Trials
12
Recruited
1,000+

Nlumn LLC

Industry Sponsor

Citations

Quantity, Duration, Adherence, and Reasons for Dietary ...

The primary reasons for dietary supplements intake included improving overall health (37.2%), maintaining health (34.7%), bone health (21.4%), and diet ...

Dietary Supplements—For Whom? The Current State of ... - PMC

The aim of this scoping review is to present what is known about the effects of using selected dietary supplements in the context of chronic diseases.

Supplements: A scorecard

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A systematic review and meta-analysis of the effects ...

Meta-analysis (39 RCT) showed ONS consumption reduced complications including infections, pressure ulcers, wound and fracture healing (OR 0.68, 95 % CI 0.59, ...

Self-reported health without clinically measurable benefits ...

Results Among 4933 adult MVM users and 16 670 adult non-users, MVM users self-reported 30% better overall health than non-users (adjusted OR 1.31; 95% CI 1.17 ...

Perspectives on the Use of Proprietary Blends in Dietary ...

This paper discusses the rationale for use of proprietary blends on dietary supplement labels, and their implications for researchers and consumers.

Questions and Answers on Dietary Supplements

Anyone may report an adverse event thought to be related to a dietary supplement directly to FDA by accessing the Safety Reporting Portal.

Safety considerations for dietary supplement ...

Responsible companies ensure that safety data supports all components used to manufacture a dietary supplement including all dietary ingredients ...

Dietary Supplement Label Database (DSLD)

It catalogs all information printed on labels of dietary supplement products sold in the United States.

CRN-Proprietary-Blends-Regulatory-Responsibilities-Best- ...

Like all dietary supplements, those containing proprietary blends are subject to federal and state requirements for safety, quality, and proper labeling. All ...