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A placebo-controlled, single-blind, crossover study to assess the effects of New Zealand pine bark extract (Enzogenol®) on glycaemic responses in healthy participants

A placebo-controlled, single-blind, crossover study to assess the effects of New Zealand pine bark extract (Enzogenol®) on glycaemic responses in healthy participants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001571167
Enrollment
25
Registered
2019-11-14
Start date
2018-03-23
Completion date
2018-11-30
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Obesity and diabetes are epidemic in New Zealand (and in other Western countries), and many individuals now have problems controlling their blood glucose levels within normal levels. More alarmingly, epidemiological studies have shown that approximately 40% of individuals with normal glucose tolerance (NGT) may still eventually develop type 2 diabetes. Research has also revealed that 20% of NGT individuals already have a certain degree of insulin resistance. Certain foods and extracts, including berries, teas and French pine bark extracts have been shown to reduce blood glucose levels. Data suggests that this may be due to the high levels of antioxidants that are present in these foods, though other substances may also be involved. The effects of New Zealand pine bark extract on blood glucose levels have not been studied, thus this study aimed to measure whether blood glucose levels could be reduced in healthy participants when taking a pine bark extract capsule at two different doses on two separate occasions with an oral glucose tolerance test (OGTT).

Interventions

The study was an acute, placebo-controlled, single-blind, crossover study consisting of 50mg and 400mg of New Zealand pine bark extract (Enzogenol®) on glycaemic responses in healthy participants. Briefly, at each visit, participants arrived at the facility after at least a 10 h overnight fast (water was allowed). The first study visit was a control visit whereby participants consumed a single placebo capsule containing only microcrystalline cellulose. The second and third visits were treatment

The study was an acute, placebo-controlled, single-blind, crossover study consisting of 50mg and 400mg of New Zealand pine bark extract (Enzogenol®) on glycaemic responses in healthy participants. Briefly, at each visit, participants arrived at the facility after at least a 10 h overnight fast (water was allowed). The first study visit was a control visit whereby participants consumed a single placebo capsule containing only microcrystalline cellulose. The second and third visits were treatment visits where patients consumed a single opaque capsule of 50 and 400mg of Enzogenol®, respectively. Each capsule was identical in appearance (size, form and colour). As this is a single-blind study, the participants did not know what dosage they were given at each visit. An OGTT was commenced at all three visits twenty minutes after consuming the capsule. Participants were given a bottle of 300 mL of glucose drink Carbotest (Fronine, Thermo Fisher Scientific, Australia) containing 75 g of carbohydrates to consume within five minutes. Capillary blood samples were obtained via finger prick with a single use disposable lancet (Accu-Chek Safe T-Pro Plus) twenty minutes before the commencement of oral glucose tolerance test (OGTT), and again at 0, 15, 30, 45, 60, 90, and 120 min after consuming the glucose drink. Blood glucose levels were immediately measured using a glucose meter (MediSense, Optium, Abbott, 2.7-4.0% CV). There was at least a washout period of 48 hour between each visit. Participants were instructed to maintain a consistent diet without any dietary alterations throughout the duration of the study. They were also asked to abstain from alcohol and beverages such as teas, coffees and energy drinks (both caffeinated and decaffeinated), all health supplements that might influence glucose metabolism, and strenuous activity during the 24h period before each visit. The participants were checked for compliance by the researcher with a checklist at each visit prior to commencing the OGTT.

Sponsors

Massey University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

• 18-40 years of age • BMI 18.5-25.0 kg/ m2 • HbA1c < 40 mmol/ mol • Fasting glucose < 5.5 mmol/ L • Not taking any medications that include blood glucose/ sugar lowering prescriptions • Not pregnant or breastfeeding • Not allergic to pine bark extract • Non-smoker • Generally healthy and not suffering from chronic diseases or diabetes • Able to communicate well in English

Exclusion criteria

Participants were excluded from the study if they had any form of cardiovascular, metabolic diseases, digestive ailments, if they smoked, were pregnant or lactating, and if they had any known allergies to pine bark extract or were taking medications or health supplements that would influence glycaemia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026