Breaking News on Supplements, Health & Nutrition - Europe US edition | APAC edition

News > Research

Read more breaking news



Human data supports bitter orange/ p-synephrine safety in humans: Nutratech

By Stephen DANIELLS , 30-Jan-2013
Last updated on 30-Jan-2013 at 16:35 GMT2013-01-30T16:35:17Z

Human data supports bitter orange/ p-synephrine safety in humans: Nutratech

Extracts from bitter orange (Citrus aurantium) on its own or combined with naringin and hesperidin do not pose any risks at doses commonly used by humans, says new data from a 60 day, double-blinded, placebo-controlled trial.

A daily dose of about 100 milligrams of a patented bitter orange extract (Advantra Z, Nutratech), alone or in combination with the other citrus flavonoids naringin and hesperidin did not produce any significant changes in systolic or diastolic blood pressures, blood chemistries or blood cell counts.

“This 60-day study is the longest study with the highest dose conducted to date involving bitter orange extract as a single entity product,” wrote the researchers in Food and Chemical Toxicology .

The study was performed by Gilbert Kaats from Integrative Health Technologies, Inc. (San Antonio), Howard Miller from Nutratech Inc. (New Jersey), Harry Preuss from Georgetown University Medical Center (Washington, DC), and Sidney Stohs from Creighton University Medical Center (Omaha).

Nutratech has been very active in supporting science about its patented bitter orange extract Advantra Z, and the New Jersey-based company funded the new study.

Commenting on the study's findings, Bob Green, Nutratech's president, told NutraIngredients-USA: "Most bitter orange safety studies, until now, have been short‑term, often based on a single dose. That’s why Nutratech welcomed the opportunity to fund a 60-day study.

"Dr. Kaats’ research not only corroborates previous safety studies, it confirms that p‑synephrine dosages (98 mg daily) even higher than those recently supported by Health Canada (50 mg) and Intertek Cantox (60 mg) can be tolerated without negative side effects.”

Growing presence in the market

Bitter orange and p-synephrine, the predominant amine in bitter orange, are claimed to increase energy expenditure, facilitate the breakdown of fat and increase glucose uptake by muscles, and is widely used in weight management and sports nutrition supplement.

The ingredient’s profile increased following the FDA ban on ephedra in 2004 as it contains similar compounds and was favored by dietary supplements manufacturers as an ephedra substitute.

Some suppliers have also reported a surge in inquiries from manufacturers looking for alternatives to controversial ingredient DMAA in the wake of the FDA’s recent crackdown on the stimulant.

P-synephrine is not banned by WADA, the FDA or Health Canada, and the latter recently changed its guidelines and concluded that 1 to 50 mg per day is “not likely to cause any adverse health consequences” .

New data

For the new study, Dr Kaats and his co-workers recruited 75 healthy men and women with an average age of 51 to participate in their study. The participants were randomly assigned to receive supplements of the bitter orange extract, or the extract plus naringin and hesperidin, or placebo for 60 days.

The researchers reported no significant changes in blood pressures, blood chemistries or blood cell counts in any of the groups. A small increase in heart rates was observed in the combination group, but this was deemed to be clinically insignificant.

“The lack of cardiovascular effects agree with previous studies where bitter orange extract was administered as a single dose and when it has been used in combination with caffeine and other ingredients that have been administered for varying periods of time,” wrote the researchers.

“Longer term studies are required to determine weight loss and the effectiveness of bitter orange (p-synephrine) as well as long term safety,” they added.

Source: Food and Chemical Toxicology
Published online ahead of print, 25 January 2013, doi: 10.1016/j.fct.2013.01.013
“A 60 Day Double-Blind, Placebo-Controlled Safety Study involving Citrus aurantium (Bitter Orange) Extract”
Authors: G.R. Kaats, H. Miller, H.G. Preuss, S.J. Stohs

Related products

Live Supplier Webinars

Polyphenols tipped to become the way to innovate in Sports Nutrition
Alpha & Omega in Sports Nutrition – Using Omega 3’s and A-GPC to improve performance and recovery.
KD Pharma
Orally bioavailable standardized botanical derivatives in sport nutrition: special focus on recovery in post-intense physical activities
Collagen in motion: move freely and keep your injuries in check
Leading manufacturer of gelatine and collagen peptides
Life’s too short for slow proteins. Whey proteins hydrolysates: Fast delivery for enhanced performance
Arla Foods Ingredients
What it Takes to Compete and Win in Today’s Sports Nutrition Market
Sports Nutrition Snapshot: Key regional drivers and delivery format innovations
William Reed Business Media
Gutsy performance: How can microbiome modulation help athletes and weekend warriors
William Reed Business Media
Pushing the boundaries: Where’s the line between ‘cutting edge nutrition’ and doping
William Reed Business Media

On demand Supplier Webinars

High-amylose maize starch may reduce the risk of type 2 diabetes: what does this qualified health claim mean?
Balancing Innovation and Risk in Sports Nutrition Ingredients
Explaining bio-hacking: is there a marketing opportunity for food companies?
William Reed Business Media
Personalized Nutrition – how an industry can take part in shaping the future of Nutrition
BASF Nutrition & Health
Find out Nutritional and ingredient lifecycle solutions and strategies!
Is the time rIpe for I-nutrition?
William Reed Business Media
The Advantage of Outsourcing Fermentation-based Manufacturing Processes
Evonik Health Care
All supplier webinars