Newsletter: September 2022

Research that is relevant

What’s New at Biofortis?

The Biofortis Project Management (PM) team is central to ensuring projects are completed on time, within budget, and with high quality. This year marks a key point, with Linda Derrig, MS, CCRA, our Director of Project and Data Management celebrating 15 years of service at Biofortis Clinical Research. Linda manages this experienced team, which includes Valerie Kaden, with 16 years of PM experience at Biofortis, and Kristen Sanoshy, MPH, with over 10 years of experience managing projects and 14 years at Biofortis. 

Jennifer Baldwin, PM Assistant, just hit her 13 year anniversary! As you can see, we have a very experienced and loyal PM team ready to take on all projects, no matter how challenging.

In addition to this experienced team, Biofortis PM has expanded to welcome a new member: Kelly Doro, Assistant PM. Kelly has been with Biofortis for one year and was a recent graduate at the University of Illinois, Champaign-Urbana, with a degree in Human Nutrition.

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Science to Support Supplement Safety

On July 13, 2022, Dr. Eunice Mah presented the findings from a recently published review of the safety and related benefits of some commonly used weight management ingredients to the Council for Responsible Nutrition (CRN) Sports Nutrition Working Group. The review was timely because many states have pending legislation that targets dietary supplements containing the components in this review based on the belief they are unsafe. Specifically at issue are weight loss and muscle-building supplements, which in these legislative proposals are defined very broadly to include an array of nutrients and food components that are thermogenic (support body heat production), lipotropic (support fat metabolism preventing its deposition in the liver), or support satiety.

The review was a collaboration among scientists at Biofortis and the Friedman School of Nutrition Science and Policy at Tufts University and conducted following standards of transparency, with full documentation of search, article selection, and level of evidence. The scope of the review covered commonly used examples of thermogens (caffeine and green tea extract [GTE]), lipotropics (choline), and satiety-supporting fibers (glucomannan) as well as newer supplement ingredients (green coffee bean extract [GCBE], capsaicinoids and capsinoids). The study was supported by a grant from CRN to independently and objectively review the safety and weight management-related health outcomes of these components, based on authoritative and consensus reports. Overall, the findings indicated weight management supplements containing caffeine, GTE, GCBE, choline, glucomannan, and capsaicinoids and capsinoids are generally safe when taken as directed and demonstrate metabolic health benefits for overweight and obese people.

The full article is available as an open-access publication: Nutrients | Free Full-Text | Dietary Supplements for Weight Management: A Narrative Review of Safety and Metabolic Health Benefits (mdpi.com)

Biofortis presents Thermogenic Energy Drink Study at ASN’s Nutrition 2022 Science to Support Supplement Safety

Thermogenic energy drinks (TEDs) are popular with people looking to lose weight, and while data often exists to support the activity of some key ingredients used in these products, manufacturers often need a study with the actual product in a population that represents the market target to make direct claims. An example of this type of clinical trial conducted by Biofortis and sponsored by Rowdy Energy was presented at the June annual meeting of the American Society of Nutrition (ASN; Nutrition 2022) by Dr. Eunice Mah.

Briefly, this randomized, double-blind, cross-over study was conducted in 30 healthy adults with age range of 18-50 years and BMI 18-30 kg/m2. Participants consumed 355 mL of the uniquely formulated zero-sugar TED beverage (caffeine, green coffee bean extract, amino acids, guarana) or 355 mL of a flavored carbonated placebo beverage on separate occasions with at least six days between each test. Compared to control, the TED beverage resulted in significantly (p< 0.05) greater resting energy expenditure (REE) over 3 h with peak REE observed at 1 h post consumption. This equated to an average of 150 kcal/d over 3 h. Subjective ratings of hunger and desire to eat were lower, and fullness was directionally increased at 3.25 h after the TED beverage compared to control. Gastrointestinal (GI) tolerance indicated the TED beverage was as well tolerated as the control beverage. Overall, the findings suggest that the TED beverage safely elicits thermogenic effects without affecting the type of fuel oxidation, while minimally, though positively affecting appetitive sensations.

Newsletter

The study abstract is available: Acute Effects of a Thermogenic Drink on Energy Expenditure. Mah E, Blonquist T, Kaden V, Jamison C. Curr Dev Nutr. 2022;6 (Suppl 1): 449. Acute Effects of a Thermogenic Drink on Energy Expenditure | Current Developments in Nutrition | Oxford Academic (oup.com)

Current Studies at Biofortis:

Biofortis is currently recruiting for several studies, including:

  • A 4-week attention study on an herbal supplement in adults 18 to 55 years old who have self-reported poor attention.
  • A study on the survival of a probiotic in a dairy-based beverage with generally healthy adults ages 18 to 40 who have regular bowel movements over 6 weeks (5 visits).
Researcher
  • Investigation of a 4-day intermittent fasting pattern (16 h fast – 8 h eating) on glycemic control using continuous glucose monitoring in non-diabetic adults ages 30 to 69.

  • Assessing appetite and fullness parameters after consuming ready-to-eat meals in healthy adults ages 25 to 65, requiring two 6-h study visits.

  • A study on the effects of a natural polyamine supplement in men ages 50 to 70 with six 1-h visits over 9 weeks.

  • A study on people who are on stable doses of statins and 40 years or older to test interventions for blood cholesterol lowering. Participants will receive an injection every 6 months for 3- to 6-years.

  • A hypertension new drug study on CIN-107, an aldosterone synthase inhibitor, is being tested in people 18 years or older with elevated blood pressure and taking a single blood pressure medication on a regular basis.

The Sensory Researchers at Biofortis regularly conduct product taste tests as well and maintain a database for taste test panelists. If you are interested in participating in any of these studies, see the Biofortis Clinical Research website: Current Studies | Dietary & Nutritional Research | Biofortis (biofortisresearch.com)

Publications with Biofortis Scientists (2021-present):

Valuing the Diversity of Research Methods to Advance Nutrition Science. Mattes RD, Rowe SB, Ohlhorst SD, Brown AW, Hoffman DJ, Liska DJ, Feskens EJM, Dhillon J, Tucker KL, Epstein LH, Neufeld LM, Kelley M, Fukagawa NK, Sunde RA, Zeisel SH, Basile AJ, Borth LE, Jackson E.
Adv Nutr. 2022 Aug 1;13(4):1324-1393.
Valuing the Diversity of Research Methods to Advance Nutrition Science - PubMed (nih.gov)

Dietary Supplements for Weight Management: A Narrative Review of Safety and Metabolic Health Benefits. Mah E, Chen O, Liska DJ, Blumberg JB. Nutrients. 2022 Apr 24;14(9):1787.
Dietary Supplements for Weight Management: A Narrative Review of Safety and Metabolic Health Benefits - PubMed (nih.gov)

Effect of COVID-19 Pandemic-Induced Dietary and Lifestyle Changes and Their Associations with Perceived Health Status and Self-Reported Body Weight Changes in India: A Cross-Sectional Survey. Madan J, Blonquist T, Rao E, Marwaha A, Mehra J, Bharti R, Sharma N, Samaddar R, Pandey S, Mah E, Shete V, Chu Y, Chen O.   Nutrients. 2021 Oct 20;13(11):3682.
Effect of COVID-19 Pandemic-Induced Dietary and Lifestyle Changes and Their Associations with Perceived Health Status and Self-Reported Body Weight Changes in India: A Cross-Sectional Survey - PubMed (nih.gov)

Citicoline and Memory Function in Healthy Older Adults: A Randomized, Double-blind, Placebo-controlled Clinical Trial.  Nakazaki E, Mah E, Sanoshy K, Citrolo D, Watanabe F. J Nutr. 2021 Aug 7; 151(8):2153-2160. NCT03369925
Citicoline and Memory Function in Healthy Older Adults: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial - PubMed (nih.gov)

A Randomized, Double-Blind, Crossover Study to Determine the Available Energy from Soluble Fiber. Canene-Adams K, Spence L, Kolberg LW, Karnik K, Liska D, Mah E. J Am Coll. Nutr.2021 Jul; 40(5):412-418.  
A Randomized, Double-Blind, Crossover Study to Determine the Available Energy from Soluble Fiber - PubMed (nih.gov)

Addition of Orange Pomace Attenuates the Acute Glycemic Response to Orange Juice in Healthy Adults. Guzman G, Xiao D, Liska D, Mah E, Sanoshy K, Mantilla L, Replogle R, Boileau TW, Burton-Freeman BM, Edirisingheet I. J Nutr 2021 Jun: 151(6):1436-1442.   NCT04369716
Addition of Orange Pomace Attenuates the Acute Glycemic Response to Orange Juice in Healthy Adults - PubMed (nih.gov)

Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults. Chen O, Blonquist TM, Mah E, Sanoshy K, Beckman D, Nieman KM, Winters BL, Anthony JC, Verdin E, Newman JC, Stubbs BJ. Nutrients. 2021 Jun; 13(6)   NCT04707989 Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults - PubMed (nih.gov) 

Effect of arabinogalactan on the gut microbiome: A randomized, double-blind, placebo-controlled, crossover trial in healthy adults.  Chen O, Sudakaran S, Blonquist T, Mah E, Durkee S, Bellamine A. Nutrition. 2021 Apr; 90:111273. NCT04351841
Effect of arabinogalactan on the gut microbiome: A randomized, double-blind, placebo-controlled, crossover trial in healthy adults - PubMed (nih.gov)

The Role of Oat Nutrients in the Immune System: A Narrative Review. Chen O, Mah E, Dioum E, Marwaha A, Shanmugam S, Malleshi N, Sudha V, Gayathri R, Unnikrishnan R, Anjana RM, Krishnaswamy K, Mohan V, Chu Y.   Nutrients. 2021 Mar 24; 13(4):1048.
The Role of Oat Nutrients in the Immune System: A Narrative Review - PubMed (nih.gov)

Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials. Weaver CM, Fukagawa NK, Liska D, Mattes RD, Matuszek G, Nieves JW, Shapses SA, Snetselaar LG. Adv Nutr. 2021 Feb 1; 12(1):21-45.
Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials - PubMed (nih.gov)

Vitamin A and D Absorption in Adults with Metabolic Syndrome versus Healthy Controls: A Pilot Study Utilizing Targeted and Untargeted LC-MS Lipidomics.   Chatelaine H, Dey P, Mo X, Mah E, Bruno RS, Kopec RE. Mol Nutr Food Res. 2021 Jan;65(2):e2000413.
Vitamin A and D Absorption in Adults with Metabolic Syndrome versus Healthy Controls: A Pilot Study Utilizing Targeted and Untargeted LC-MS Lipidomics - PubMed (nih.gov)

 

For a full list of publications see  Publications - Biofortis Research