Clinical trial NCT04258501: Exploratory Study of Efficacy on Selected Natural Extracts Reducing Post Prandial Blood Glucose Response
Official title: An Exploratory Study of Efficacy and Tolerance on Selected Natural Extracts, With the Potential of Reducing Post Prandial Blood Glucose Response, in Healthy Indian Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Lambda Therapeutic Research Ltd.
First posted: 2020-02-06
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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).
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Is the volunteer willing to give his consent to participate in the study in writing?
2. Is the volunteer between the age of \>20 and \<50 yrs?
3. Is the volunteer's Body Mass Index (BMI) in between \>18 and \<25 kg/m2?
4. Lactase deficient as indicated by screening test1
5. Is the volunteer apparently healthy? \[No medical conditions which might affect study measurement, as judged by study physician or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis\]
6. Is the volunteer willing to comply to study protocol during the study?
7. Is the volunteer agreeing to be informed about medically relevant personal test-results by study physician?
8. Is the volunteer willing to refrain from drinking of alcohol on and one day before the blood withdrawal?
9. Is the fasting blood glucose value of the volunteer is \>3.4 and \<6.1 mmol/ litre (i.e. 62-110 mg/dl)?
10. Is the Haemoglobin level within normal reference range as judged by the research physician?
11. Is the volunteer literate?

Exclusion Criteria:

1. Is the volunteer an employee of Unilever, Hindustan Lever, or Lambda Therapeutics Research?
2. 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?
3. Does the volunteer take too much of alcohol (\> 120 ml / week)?
4. Is the volunteer on a medically prescribed/slimming diet?
5. Does the volunteer work in night shifts (between 23.00 and 6.00 hrs) in the week preceding or during the study?
6. 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?
7. 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)
8. Has the volunteer reported weight loss/gain \> 10% of body weight in the 6 months preceding screening?
9. Has the volunteer donated any blood for 2 months prior to screening visit?
10. Does the volunteer urine analysis show any drug abuse?
11. Is the volunteer allergic to any food or cosmetics?
12. 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?
13. If female, is the volunteer pregnant or will she be planning pregnancy during the study period?
14. If female, is the volunteer lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period?

Primary outcomes:
measure: Post-prandial blood glucose
timeFrame: Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours.
Secondary outcomes:
measure: Breath hydrogen excretion
timeFrame: Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products
measure: Intestinal discomfort
timeFrame: Ten minutes before (baseline) and at 130, 250, 370 and 420 minutes after the ingestion of the test products.
measure: Stool consistency and number of stools
timeFrame: 24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview).
Other outcomes:
measure: Post-prandial serum insulin
timeFrame: Total Area under the insulin versus time Curve 0-2 hours after the intake.
measure: Glucose in urine
timeFrame: Subjects were asked to empty their bladder before study product intake (-20 minutes) and again before leaving the site ( 450 minutes). In these two samples and in all additional urine samples voided while subjects were on site, glucose was analyzed
Locations:
city: Ahmedabad
country: India
facility: Lambda Therapeutics Research Ttd
state: Gujarat
Study officials:
affiliation: Unilever R&D Vlaardingen (retired)
name: David Mela, Dr.
role: STUDY_DIRECTOR
References:
citation: Mela DJ, Cao XZ, Dobriyal R, Fowler MI, Lin L, Joshi M, Mulder TJP, Murray PG, Peters HPF, Vermeer MA, Zhang Z. The effect of 8 plant extracts and combinations on post-prandial blood glucose and insulin responses in healthy adults: a randomized controlled trial. Nutr Metab (Lond). 2020 Jul 6;17:51. doi: 10.1186/s12986-020-00471-x. eCollection 2020.