NCT03897517

Brief Summary

This project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

August 30, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

March 25, 2019

Last Update Submit

August 26, 2019

Conditions

HyperglycemiaCarbohydrateInsulin ResistanceMalabsorption

Keywords

GlycemiaCarbohydrate blocker

Outcome Measures

Primary Outcomes (2)

  • Post Prandial Glycemia

    Plasma glucose concentrations after the ingestion of a high carbohydrate meal

    3 weeks

  • Breathe hydrogen concentration

    Measurement of hydrogen in exhaled air as an indicator of carbohydrate absorption

    3 weeks

Study Arms (2)

Proprietary Botanical Blend

EXPERIMENTAL

Proprietary Botanical Blend - Dietary supplement with alpha amylase and sucrase inhibitory activity. 2 capsules

Dietary Supplement: Proprietary Botanical Blend

Placebo

PLACEBO COMPARATOR

Non/minimally nutritive nonactive material: rice flour. 2 capsules

Dietary Supplement: Placebo

Interventions

Proprietary Botanical BlendDIETARY_SUPPLEMENT

Oral administration of capsules containing proprietary botanical blend 30 minutes prior to carbohydrate ingestion.

Proprietary Botanical Blend
PlaceboDIETARY_SUPPLEMENT

Oral administration of capsules containing rice flour (placebo) 30 minutes prior to carbohydrate ingestion.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-65 years
  • Men and women
  • Able to provide written consent in English
  • A body mass index between 23.0 and 30.0 kg/m2
  • A fasting serum blood glucose level between 100.0 and 126.0 mg/dL

You may not qualify if:

  • Current smoker
  • Having a BMI less than 23.0 kg/m2 and higher than 30.0 kg/m2
  • Having a fasting blood glucose level less than 100.0 mg/dL and higher than 126.0 mg/dL
  • Suffering from known serious cardiac, hepatic, renal, pulmonary, gastrointestinal, endocrine or hematological disease based on investigator determination, aside from pre-diabetes
  • Currently pregnant or breastfeeding
  • Consuming more than 2 alcoholic drinks per day on average.
  • Weight loss of more than 5% of body weight over the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Augustin LSA, Kendall CWC, Jenkins DJA, Willett WC, Astrup A, Barclay AW, Bjorck I, Brand-Miller JC, Brighenti F, Buyken AE, Ceriello A, La Vecchia C, Livesey G, Liu S, Riccardi G, Rizkalla SW, Sievenpiper JL, Trichopoulou A, Wolever TMS, Baer-Sinnott S, Poli A. Glycemic index, glycemic load and glycemic response: An International Scientific Consensus Summit from the International Carbohydrate Quality Consortium (ICQC). Nutr Metab Cardiovasc Dis. 2015 Sep;25(9):795-815. doi: 10.1016/j.numecd.2015.05.005. Epub 2015 May 16.

    PMID: 26160327RESULT

Related Links

MeSH Terms

Conditions

HyperglycemiaInsulin ResistanceMalabsorption Syndromes

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Lilian de Jonge

CONTACT

7039935153edejonge@gmu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Treatment and placebo will be matched closely in color and appearance administered in a double blinded fashion as provided by the material supplier.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Participants will receive both treatments in random order with a washout period of at least 1 week between the 2 study visits. Women will be measured during the follicular phase of the menstrual cycle.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 1, 2019

Study Start

August 30, 2019

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08