Our Services

 Frestedt Incorporated provides services for drugs, biologics and devices.
Alimentix provides services for foods, food ingredients and dietary supplements.
Frestedt Learning Center offers customized training events.

Green Alimentix logo

Alimentix is a comprehensive clinical investigation center (clinical trial site) dedicated to conducting clinical trials for foods, food ingredients, dietary supplements, natural products, over the counter pharmaceuticals and non-significant risk medical device products.

What We Do

Alimentix provides scientific substantiation for “health effects” or “claims” with independent, timely, scientifically-designed clinical trials at a reasonable cost. We design clinical trials for minimal risk drugs and other low risk research activities:

  • Human factors testing
  • Label comprehension studies
  • Novel human interactions with foods, drugs, and devices
Bowl with yogurt, granola, and blueberries, with a spoon next to it

Alimentix strives to be the leading clinical research investigative center for foods, food ingredients, dietary supplements, natural products, over the counter pharmaceuticals and non- significant risk medical device products.

We excel by providing innovative, cost effective and increasingly virtual options to complete research with speed and accuracy in order to enable our clients to market their products with appropriate clinical data and regulatory documentation supporting all claims.

woman wearing a face mask looking into microscope

Why Alimentix?

You need fast, efficient, and comprehensive clinical trials to test the safety and effectiveness of your product. Alimentix is the perfect combination of scientific expertise, business acumen and reliable partnership. We can help you verify product quality, meet regulatory requirements and get your product to the market—fast. We care about safety, effectiveness and cost. We work to understand your business needs, we provide the customization and flexibility you require and we guide you toward the result you want.

Our value proposition: Lower risk should equal lower cost.

With thousands of new products reaching the market each year, we believe the demand for novel research centers like Alimentix is increasing. Our value proposition is unique. Many research sites cost more because they are designed for high-risk products and require expensive oversight functions to ensure patient safety. We fill a specific niche by focusing effort directly on “low-risk” products with adequate and appropriately designed patient safety oversight features to control costs. We enroll patients into our trials quickly and efficiently to complete the research on time and on budget.

Our customized service: Specific claims should have specific data.

In this underserved market, we are experts in designing low cost and tightly focused clinical trials or literature reviews for low-risk products of all types. We provide scientifically rigorous data and we communicate the scientific information clearly and accurately to scientists, regulators and consumers. We provide scientific substantiation documents as well as regulatory submission dossiers for health claims about foods, food ingredients, dietary supplements, natural products, low risk medical devices and over the counter drugs.

Our collaborative approach: We extend your team!

We work with you to find a cost and time effective option to complete your clinical, regulatory or quality development work. We have all the specialists you need to get concrete, dependable answers. We can design and conduct your clinical trial or we can conduct a literature review and write a clinical evidence report to substantiate your claim. We can also work with you to negotiate your position with regulatory authorities or to create your quality systems to meet regulatory requirements. We can even develop quality management system documents and training to help the team complete these complex tasks.

What we provide

Alimentix has comprehensive and deep bench strength in science as well as clinical trials, regulatory affairs and quality systems. We combine our background knowledge with an extensive experience conducting clinical trials. We develop and manage pre-clinical, proof of concept and clinical study protocols including customized diets for food product comparisons and we have designed customized questionnaires for product uses and human factors engineering testing. We also provide study monitoring services, statistical data analyses and we can write and publish the study results if desired.

Green Apple

Alimentix provides all types of clinical research services:

  • Protocol Development
  • Study Design
  • Customized Diet Design
  • Informed Consent
  • Case Report Forms
  • Clinical Personnel Training
  • Forms Development
  • Clinical Study Training
  • Trial Registration
  • Site Preparation
  • Subject Recruitment
  • Study Monitoring and Auditing
  • Data Collection
  • Data/Diet Analysis
  • Biostatistical Analyses
  • Adverse Event Reporting
  • Quality Audits
  • Clinical Study Report Writing
  • FDA/FTC Submissions
  • Regulatory Services
  • Product Support
  • Publication Support
  • Speaker Support

In addition to our clinical trial related work, we can provide assistance with the following areas:

  • Development of Marketing Materials
  • Label Comprehension Studies
  • Human Factors Engineering Testing
  • Taste & Texture Studies
  • Generally Recognized as Safe (GRAS) Expert Panels and Reports
  • New Dietary Ingredient Submissions to the FDA

Case Studies

Situation:

Leading food ingredient company desired “gold standard” claim substantiation evidence supporting the claim: Product X improves human glucose/insulin management.

 

Task:

Develop, execute, publicize “world class” clinical trial supporting intended claim.

 

Actions Taken:

Designed randomized, double-blind, placebo-controlled trial; selected clinical trial sites and specialized study experts; designed diet plans and nutritional counseling activities to maintain subject weight; and monitored study sites.

 

Results:

Isolate the effects of the investigative product on glucose/insulin levels in healthy, hyperglycemic individuals; analyzed data (including diet diaries using specialized nutritional software) and completed comprehensive publication strategy to communicate results.

 

Benefit 1:

Expertise added to corporate team : Alimentix provided subject matter expertise (company lacked knowledge/experience designing, developing and running clinical trials and this trial required specialized, nutritional counseling, diet analysis and laboratory medicine expertise).

 

Benefit 2:

Flexibility added to trial execution: Alimentix added a second site to increase subject recruitment activities and reduced time to completion of trial.

 

Benefit 3:

Prestige added to product visibility: Alimentix published results in 5 food-related conferences (4 US, 1 international) and 2 peer-reviewed journals.

Situation:

Large, global company required post-market surveillance of all safety reports for their new dietary supplement food product (first in class; new brand).

 

Task:

Developed system to track all adverse events (AE) and communicate results.

 

Actions Taken:

Developed specialized call center to log, categorize, track and report all AE calls using downloadable access.

 

Results:

Provided monthly reports and multi-year comprehensive safety overviews (developed individual categories and statistical trends analyses).

 

Benefit 1:

Safety oversight expertise added to corporate team: Alimentix provided subject matter expertise (company lacked knowledge/experience receiving/tracking safety reports, designing, developing and running call center to collect AE reports from callers, and this work required specialized, clinical safety expertise in immunology, nutritional counseling, dietary safety and laboratory medicine).

 

Benefit 2:

Increased productivity of corporate team: Monthly report always completed on time and not as an “add on” responsibility for company staff.

 

Benefit 3:

Novel scientific observations recorded in real time: Company notified of significant trends in real time and facilitated development of new clinical trial ideas to support safety initiatives.

 

Benefit 4:

Regulatory reporting facilitated: Company received comprehensive and detailed monthly summary and updated overview/annual reports for submission to the FDA or others to meet new safety reporting requirements.

 

Situation:

A mid-sized device company required a new process for clinical evaluation of the medical literature. Their current systems were under great scrutiny and lacked adequate/appropriate development and expertise during execution.

 

Task:

Developed methods to research, acquire, review, evaluate and report the clinical evaluation of appropriately selected medical literature in a structured, scientifically accepted manner and use this method to evaluate specific claims for company products under review.

 

Actions Taken:

Developed Standard Operating Procedures (SOPs), Work Instructions, Forms and training and completed required clinical evaluation reports.

 

Results:

Robust, comprehensive clinical evaluation processes are now being used (including detailed steps to: acquire and review appropriately selected medical literature, rate the strength/quality of the evidence and report the overall strength of the claim substantiation).

 

Benefit 1:

Expertise added to corporate team: Alimentix provided subject matter expertise (company lacked knowledge/experience using clinical evaluation reports according to international standards to substantiate claims).

 

Benefit 2:

Increased productivity of corporate team: Completed project within 3 weeks, not possible in-house (documented claim substantiation/level of the evidence in systematic, detailed reports with recommendations regarding the use of specific claims and wording).

 

Benefit 3:

Novel scientific observations recorded in real time: Company notified of significant trends in real time and facilitated development of new clinical trial ideas to support safety initiatives.

 

Benefit 4:

Decreased variability and duplication of efforts during clinical evaluation of claims: Aligned literature reviews in comprehensive standardized process with formal documentation including centralized document library to be used for future clinical evaluations.

Situation:

A leading smoothie type beverage supplier wanted to make a claim about weight loss regarding their beverage. In order to make product claims, they required scientific substantiation.

 

Frestedt Approach:

  • Selected and trained company on appropriate claims
  • Defined trial design and developed trial protocol
  • Created informed consent, Case Report Form and source document templates
  • Created database and statistical analysis plan
  • Selected IRB
  • Submitted and tracked all documentation through IRB approval
  • Generated recruitment campaign and enrolled all study subjects
  • Conducted trial within Alimentix: The Minnesota Diet Research Center
  • Wrote final study report, authored several abstracts and published manuscript

 

Results:

Alimentix designed the clinical trial with an intended goal for subjects to safely lose approximately 1 pound of excess weight per week. During the 12 week trial, study subjects (on average) lost the expected weight, stated they were not hungry and they felt satiated (which were measured attributes followed during the trial). At the request of the sponsor, an abstract for a poster presentation and manuscript were submitted. The poster was presented at a national clinical research conference, and was a finalist in the poster competition.