How a combination of mulberry leaf, berberine, and chromium impacts weight and sugar metabolism in adults
| ISRCTN | ISRCTN39970779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39970779 |
| Sponsor | Hellenic Institute of Nutrition |
| Funder | Hellenic Institute of Nutrition |
- Submission date
- 11/07/2026
- Registration date
- 15/07/2026
- Last edited
- 15/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity can increase the risk of health problems such as type 2 diabetes and heart disease. Researchers wanted to find out whether a supplement containing three ingredients, berberine, white mulberry leaf extract, and chromium, could help adults with obesity reduce body fat and improve the way their bodies process sugar. The study compared this supplement with a placebo (a dummy treatment that contains no active ingredients).
Who can participate?
Adults aged 18 to 65 years with obesity (body mass index (BMI) of at least 30 kg/m²) and no other diagnosed chronic diseases could take part. Participants had to be willing to give written informed consent before joining the study.
People could not take part if they were pregnant or breastfeeding, planned to become pregnant during the study, had diabetes treated with insulin or diabetes medicines, had significant liver or kidney problems, had previous or planned weight-loss surgery, were allergic to any of the study ingredients, were taking certain medicines such as anticoagulants, were using other weight-loss or blood sugar supplements, had recently taken part in another clinical trial, or had another diagnosed chronic disease.
What does the study involve?
Participants were randomly assigned to receive either the active supplement or a placebo. Neither the participants nor the researchers knew which treatment each person received until the study had finished.
The active supplement contained berberine, white mulberry leaf extract, and chromium. Participants took the study treatment twice a day before their main meals for 12 weeks.
Participants were asked to keep their usual diet and physical activity levels unchanged during the study. Researchers monitored this using food diaries, diet questionnaires, physical activity questionnaires, and weekly compliance forms.
At the start of the study and again after 12 weeks, participants had measurements of their BMI, body fat, and visceral fat (fat around the internal organs). They also completed a glucose tolerance test, which involved drinking a glucose solution and having blood samples taken over the following 2 hours to measure blood sugar and insulin levels.
What are the possible benefits and risks of participating?
Participants receiving the supplement experienced greater reductions in weight, total body fat, and visceral fat, and showed improvements in measures of blood sugar control compared with participants receiving the placebo.
The reported side effects were generally mild and mainly involved stomach discomfort. As with any research study, participants may also have experienced inconvenience from attending study visits, completing questionnaires, and having blood tests.
Where is the study run from?
The study was carried out at Athens Euroclinic Hospital in Athens, Greece.
When is the study starting and how long is it expected to run for?
The first participant joined the study on 19 November 2024. Recruitment finished on 10 December 2024. Each participant took part in the study for 12 weeks. The study was completed on 8 April 2025.
Who is funding the study?
The study is funded by the Hellenic Institute of Nutrition.
Who is the main contact?
Dr Konstantinos Xenos
nutrixen@yahoo.gr
Contact information
Scientific, Principal investigator, Public
Lazaraki 35
Glyfada
16675
Greece
 ORCID ID |
0009-0002-9075-959X |
|---|---|
| Phone | +30 6977747474 |
| nutrixen@yahoo.gr |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Prevention, Treatment |
| Scientific title | Effects of berberine, white mulberry leaf extract and chromium picolinate on body composition and insulin resistance in adults with obesity: a randomized controlled trial |
| Study objectives | |
| Ethics approval(s) |
Approved 12/11/2024, Ethics Committee of Athens Euroclinic Hospital (Athanasiadou 7-9, Athens, 11521, Greece; +30 21 0641 6600; kxenos@euroclinic.gr), ref: 5/12.11.2024 |
| Health condition(s) or problem(s) studied | Obesity, Insulin Resistance |
| Intervention | Study design A 12-week, randomized, double-blind, placebo-controlled, parallel-group trial conducted at a single center (Athens Euroclinic Hospital), approved by the hospital's Ethics Committee. Interventions Active: a fixed-dose combination taken in two divided doses before main meals: Berberine hydrochloride 1000 mg (≈970 mg pure berberine) White mulberry (Morus alba) leaf extract 400 mg, standardized to 5% DNJ (1-deoxynojirimycin), providing 20 mg DNJ Chromium picolinate 0.644 mg Comparator: matched placebo Dosing was based on prior clinical literature for each ingredient rather than a dose-finding step in this trial Randomization and blinding 1:1 allocation via a computer-generated sequence created by an independent statistician; the code stayed masked to investigators and participants until database lock. Controlling for lifestyle confounds Participants were instructed to hold their baseline diet and activity constant, monitored via: 3-day food diaries at weeks 0, 6, 12 A semi-quantitative Food Frequency Questionnaire at weeks 0 and 12 IPAQ physical activity questionnaire at weeks 0, 6, 12 Weekly compliance forms for supplement adherence and habit stability |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 08/04/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 110 |
| Total final enrolment | 104 |
| Key inclusion criteria | 1. Adults with obesity — BMI ≥ 30 kg/m² 2. Otherwise healthy — free of any other diagnosed chronic disease 3. Willing and able to provide written informed consent prior to enrolment 4. Recruited via advertisements at Athens Euroclinic Hospital |
| Key exclusion criteria | 1. Pregnancy, breastfeeding, or plans to become pregnant during the study period 2. Diagnosed type 1 or type 2 diabetes mellitus currently treated with insulin or oral hypoglycaemic agents 3. Significant hepatic impairment or renal insufficiency 4. Prior bariatric surgery or planned bariatric surgery during the study period 5. Known hypersensitivity or allergy to berberine, mulberry, or chromium-containing compounds 6. Current use of anticoagulant or antiplatelet therapy 7. Use of any other weight-loss, glucose-lowering, or insulin-sensitizing nutritional supplement within 4 weeks prior to screening 8. Participation in another interventional clinical trial within 3 months prior to enrolment 9. Presence of any other diagnosed chronic disease |
| Date of first enrolment | 19/11/2024 |
| Date of final enrolment | 10/12/2024 |
Locations
Countries of recruitment
- Greece
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
15/07/2026: Trial's existence confirmed by Ethics Committee of Athens Euroclinic Hospital.
