NCT02780206

Brief Summary

Understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by very low calorie diet procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

May 19, 2016

Last Update Submit

February 3, 2022

Conditions

ObesityVery Low Calorie Diet

Outcome Measures

Primary Outcomes (1)

  • Change in net whole-body protein synthesis

    Change in whole-body protein synthesis rate after intake of meal

    0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min

Secondary Outcomes (17)

  • Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)

    Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3

  • Executive Function-Adolescent/Adult Sensory Profile (ASP)

    Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3

  • Group differences in quality of life as measured by Short Form (36) Health Survey (SF36)

    Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3

  • Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)

    Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3

  • Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)

    Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3

  • +12 more secondary outcomes

Study Arms (1)

obese

EXPERIMENTAL

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical and psychological information about them that will help determine study eligibility or can be used for later coding. 3 study days (one baseline, one approx 2 weeks of diet, one post-diet): muscle mass and function tests, resting energy expenditure, stable isotope infusions with blood draws, and questionnaires regarding quality of life, mood and depression, diet.

Other: Stable isotope amino acid infusion

Interventions

Stable isotope amino acid infusionOTHER

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

obese

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • · (Possible) pregnancy Any other condition according to the PI or nurse that would interfere with the study or safety of the patient Failure to give informed consent Use of protein or amino acid containing nutritional supplements within 3 days of first test day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77843, United States

Location

Related Publications (1)

  • Wierzchowska-McNew RA, Engelen MPKJ, Thaden JJ, Ten Have GAM, Deutz NEP. Obesity- and sex-related metabolism of arginine and nitric oxide in adults. Am J Clin Nutr. 2022 Dec 19;116(6):1610-1620. doi: 10.1093/ajcn/nqac277.

    PMID: 36166849DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marielle Engelen

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 23, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

February 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)