Evidence map›Paper›PMID 31308360›Full record

Trial reportNutrition & diabetes2019

Development of a delayed-release nutrient for appetite control in adults with obesity and type 2 diabetes and initial clinical testing in a single dose randomized controlled trial.

E Beale, E Lim, H Yassine, C Azen, C Christopher

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrition & diabetes, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.7field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 6 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

E BealeDivision of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA. beale@usc.edu.ORCID http://orcid.org/0000-0003-4360-7745
E LimSC CTSI, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.ORCID http://orcid.org/0000-0001-5464-8759
H YassineDivision of Endocrinology and Diabetes, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.
C AzenSC CTSI, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90033, USA.
C ChristopherCaliVive Inc., San Mateo, CA, 94402, USA.
University of Southern California · US

Funding

Southern California Clinical and Translational Science InstituteUL1TR001855 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Thomas A Buchanan, Michele D. Kipke · 2016 to 2026
$81.3M
Southern California Clinical and Translational Science InstituteUL1TR000130 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI BUCHANAN, THOMAS A · 2012 to 2015
$36.0M
NCATS NIH HHS UL1 TR000130NCATS NIH HHS UL1 TR001855
6 · The paper itself

Abstract

BACKGROUND AND

objectivesDelivery of nutrients directly to the small intestine, either via enteral feeding tube or by gastric bypass surgery, is associated with increased levels of appetite-suppressing and glucoregulatory hormones, including GLP-1, and reduced appetite. Achieving these changes non-invasively using formulated foods may be of therapeutic benefit in individuals with obesity and related comorbidities. The aim of this pilot study was to determine the effect of a single dose of a novel delayed-release nutrient (DRN) on glucose, GLP-1, c-peptide, insulin, and appetite in adults with obesity and type 2 diabetes. SUBJECTS AND

methodsWe formulated an all-natural, generally recognized as safe ('GRAS") DRN and conducted a randomized prospective crossover trial. Nineteen adults with obesity and type 2 diabetes underwent paired 3-h meal tolerance tests (MTT) in randomized order 1-4 weeks apart. Subjects ingested a single dose of DRN and the same nutrients as unformulated powders (UN).

resultsFor DRN compared with UN, the maximal concentration (Cmax) was significantly lower for glucose, c-peptide, and insulin, and the time of maximal concentration (Tmax) was significantly delayed. While Tmax for GLP-1 was also significantly delayed following DRN compared with UN (45 min later; p = 0.26), Cmax did not differ significantly. GLP-1 rose significantly during the last 90 min of the 3-h MTT (β

conclusionsWe conclude that nutrient can be formulated using all-natural ingredients to induce a delayed rise in GLP-1. Further testing is needed to determine the amount and site of nutrient release, when maximum GLP-1 levels occur, and if modification of the formulation specifications and dose are associated with appetite and glucose control.

Indexed as

Dietary SupplementsAdultAppetiteAppetite RegulationBlood GlucoseC-PeptideCross-Over StudiesDiabetes Mellitus, Type 2Energy IntakeFemaleGlucagon-Like Peptide 1HumansInsulinMaleMiddle AgedObesityBlood GlucoseC-PeptideGlucagon-Like Peptide 1Insulin

Identifiers

PMID31308360
PMCPMC6629646
OpenAlexW2961238543

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.