Exploratory Study of Efficacy on Selected Natural Extracts Reducing Post Prandial Blood Glucose Response
Status
Completed
Conditions
Blood Glucose
Treatments
Other: Apple
Other: White bean
Other: Mulberry leaf
Other: Mulberry fruit
Other: Elderberry
Other: Rice porridge
Other: Turmeric
Details and patient eligibility
About
Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).
Full description
Incomplete block design cross over study in which the subjects consumed commercial rice porridge (60 grams of extruded rice to which 300 ml of boiling water was added) in the morning in a fasted state. On each visit one of the seven different natural exacts was mixed into this porridge just before consumption. The reference was consumed by all subjects and consisted of plain porridge with no extract added.
Enrollment
72 patients
Sex
All
Ages
20 to 50 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Is the volunteer willing to give his consent to participate in the study in writing?
- Is the volunteer between the age of >20 and <50 yrs?
- Is the volunteer's Body Mass Index (BMI) in between >18 and <25 kg/m2?
- Lactase deficient as indicated by screening test1
- Is the volunteer apparently healthy? [No medical conditions which might affect study measurement, as judged by study physician or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis]
- Is the volunteer willing to comply to study protocol during the study?
- Is the volunteer agreeing to be informed about medically relevant personal test-results by study physician?
- Is the volunteer willing to refrain from drinking of alcohol on and one day before the blood withdrawal?
- Is the fasting blood glucose value of the volunteer is >3.4 and <6.1 mmol/ litre (i.e. 62-110 mg/dl)?
- Is the Haemoglobin level within normal reference range as judged by the research physician?
- Is the volunteer literate?
Exclusion criteria
- Is the volunteer an employee of Unilever, Hindustan Lever, or Lambda Therapeutics Research?
- Has the volunteer participated in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the study period?
- Does the volunteer take too much of alcohol (> 120 ml / week)?
- Is the volunteer on a medically prescribed/slimming diet?
- Does the volunteer work in night shifts (between 23.00 and 6.00 hrs) in the week preceding or during the study?
- Is the volunteer using any medication including traditional medicines, vitamins, tonics which might interfere with study measurements, as judged by the PI and/or study physician?
- Does the volunteer engage in intense exercise > 10h/week? (Intense exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation)
- Has the volunteer reported weight loss/gain > 10% of body weight in the 6 months preceding screening?
- Has the volunteer donated any blood for 2 months prior to screening visit?
- Does the volunteer urine analysis show any drug abuse?
- Is the volunteer allergic to any food or cosmetics?
- Does the volunteer smoke or consume tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study?
- If female, is the volunteer pregnant or will she be planning pregnancy during the study period?
- If female, is the volunteer lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period?
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
72 participants in 9 patient groups, including a placebo group
Mulberry fruit extract
Experimental group
Description:
1.5 g of mulberry fruit powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: Mulberry fruit
Mulberry leaf extract
Experimental group
Description:
1.0 g of mulberry leaf powdered extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: Mulberry leaf
White bean extract
Experimental group
Description:
3 g of white bean powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: White bean
Apple extract
Experimental group
Description:
2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: Apple
Elderberry extract
Experimental group
Description:
2 g of elderberry powder extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: Elderberry
Turmeric extract
Experimental group
Description:
0.18 g of curcumin powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: Turmeric
Turmeric extract + Apple extract
Experimental group
Description:
0.18 g of curcumin powdered extract + 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: Turmeric
Other: Apple
Turmeric extract + Elderberry extract
Experimental group
Description:
0.18 g of curcumin powdered extract + 2 g of elderberry powder extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: Turmeric
Other: Elderberry
Rice porridge control
Placebo Comparator group
Description:
Bowl containing 60 g of extruded rice + 300 ml of boiling water
Treatment:
Other: Rice porridge
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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