Effects of Hintonia latiflora in type 2 diabetics

ISRCTN	ISRCTN83308122
DOI	https://doi.org/10.1186/ISRCTN83308122
Secondary identifying numbers	Gehrlicher 01/2007

Submission date: 31/08/2012
Registration date: 07/09/2012
Last edited: 27/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
We were carrying out a study to measure the effect of a dietary supplement containing an extract from the bark of the South American tree Hintonia latiflora on blood sugar control. The aim of the study was to see if preparations of this plant extract are useful in the treatment of local cases of diabetes.

Who can participate?
Adults suffering from age-related diabetes.

What does the study involve?
Participants will take one capsule before meals twice daily while adhering to the prescribed diet. Only routine examinations will be carried out during the study, such as measurement of blood sugar values and HbA1c as a parameter for long-term development of diabetes.

What are the possible benefits and risks of participating?
A delay of the requirement of treating diabetics with insulin is a clinical target in diabetes therapy, and increases the quality of life of patients. No adverse reactions have been observed in previous examinations and experience with exposure to Hintonia bark preparations. Participating patients are screened for potential adverse events.

Where is the study run from?
A medical diabetes center.

When is the study starting and how long is it expected to run for?
The study started in 2009 and was stopped in 2011.

Who is funding the study?
Gehrlicher Pharmazeutische Extrakte in Eurasburg/Obb., Germany.

Who is the main contact?
Dr Marta Korecova
Korecova.dea@stonline.sk

Contact information

Dr Marta Korecova
Scientific

Head of Diabetes Department
IDF President
Rc: 425201/734
Velkomoravská 2
Trencin
91101
Slovakia

Email	Korecova.dea@stonline.sk

Study information

Study design	Open prospective dietary intervention study with a duration of 6 months
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Six-month clinical trial to investigate the effect of Hintonia latiflora in the dietetic treatment of mild and moderate type 2 diabetes mellitus
Study hypothesis	Intake of capsules with an extract of the bark of the South American plant Hintonia latiflora as a dietary measure contributes to controlling and improving parameters of diabetes mellitus.
Ethics approval(s)	Not provided at time of registration
Condition	Mild and moderate diabetes mellitus of type II (age-related)
Intervention	Sucontral® D Capsules, Harras Pharma Curarina, Munich, with 100 mg of a dry concentrate per capsule (extraction solvent ethanol 32°%) from the bark of the Central American plant Hintonia latiflora (SESSÉ & MOC. ex DC.) BULLOCK (Rubiaceae). The plant material came from controlled collection. Per capsule, 24 mg polyphenols are supplied. The capsules also contained 30 mg vitamin C, 5 mg vitamin E, 0.7 mg vitamin B1, 0.8 mg vitamin B2, 1 mg vitamin B6, 0.5 µg vitamin B12, 100 µg folic acid, 75 µg biotin, 2.5 mg zinc and 25 µg chromium. 1 capsule before meals twice daily while adhering to the prescribed diet.
Intervention type	Other
Primary outcome measure	Fasting blood sugar and postprandial blood sugar (two hours after food intake) as well as blood pressure and body weight were recorded at monthly intervals. The HbA1c value was recorded after three and six months as were the liver values and blood lipids.
Secondary outcome measures	1. Safety laboratory including liver function tests 2. Physical symptoms 3. Adverse events
Overall study start date	01/01/2008
Overall study end date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	30-40
Participant inclusion criteria	1. Type 2 diabetics 2. Between the ages of 45 and 80 3. Neither oral antidiabetic agents nor insulin were used 4. Prescribed diet had led to stable but not nearly normoglycaemic values As a condition for inclusion in the study, diabetic symptoms must have existed for a period of at least 12 months. The values for fasting blood sugar had to be in the range from 7-14 mmol/l (normal value: 3.9-5.4 mmol/l).
Participant exclusion criteria	To be excluded were patients for whom there was a doubt about the reliability with respect to the adherence to the dietetic guidelines (e.g., with regard to alcohol consumption). Other exclusion reasons were severe diabetic symptoms, progressive life-threatening diseases, hepatic dysfunction or renal insufficiency (deviations of GOT, γGT and AP of more than twice the normal value, serum creatinine > 130 µmol/l), hypoglycaemic crises not noticed in time, retinopathy, pregnancy, malignant tumours and/or drug or alcohol dependence in the medical history.
Recruitment start date	01/01/2008
Recruitment end date	31/12/2011

Locations

Countries of recruitment

Slovakia

Study participating centre

Head of Diabetes Department

Trencin
91101
Slovakia

Sponsor information

Gehrlicher Pharmazeutische Extrakte GmbH (Germany)
Industry

Robert-Koch-Str. 5
Eurasburg
82547
Germany

Phone	+49 8179 99779 0
Email	production@gehrlicher.de
Website	http://www.gehrlicher.de
"ROR"	https://ror.org/04qx49k93

Funders

Funder type

Industry

Gehrlicher Extrakte (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/03/2014		Yes	No