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Very Low Calorie Diet Weight Loss

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780206
First Posted: May 23, 2016
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University
  Purpose
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.

Condition Intervention
Obesity Very Low Calorie Diet Other: Stable isotope amino acid infusion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Omics Profiling of the Response to Food and Variability of Weight Loss in Medically Supervised Very Low Calorie Diet

Resource links provided by NLM:


Further study details as provided by Marielle PKJ Engelen, PhD, Texas A&M University:

Primary Outcome Measures:
  • Change in net whole-body protein synthesis [ Time Frame: 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 ]
    Change in whole-body protein synthesis rate after intake of meal


Secondary Outcome Measures:
  • Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    a fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.

  • Executive Function-Adolescent/Adult Sensory Profile (ASP) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.

  • Group differences in quality of life as measured by Short Form (36) Health Survey (SF36) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT)

  • Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    questionnaire is intended for use in an elderly population and focuses on 3 types of activities: leisure time activities, household activities and work-related activities.

  • Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    a word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The total time in seconds was reported for each trial.

  • Group differences in state of mood as measured by the Profile of Mood State (POMS) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. Healthy populations take 3 to 7 minutes to complete, and others may take up a bit longer.

  • Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    Controlled Oral Word Association Test (COWAT): The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total and mean words recorded across the three trials) was reported.

  • Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    Auditory Verbal Learning Test (AVLT): a verbal episodic memory test that evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, retention and recognition of information

  • Group differences in attention and executive functions as measured by PASAT [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.

  • Group differences in attention and executive functions as measured by Trail Making Test (TMT) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure.

  • Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.

  • Group differences in attention and executive functions as measured by Brief-A [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 ]
    a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.

  • Skeletal muscle strength [ Time Frame: on study day 1 and the change from day 2 and day 3 ]
    handgrip and kin-com 1-leg test

  • 24 hour diet recall [ Time Frame: on study day 1 and the change from day 2 and day 3 ]
    The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.

  • Respiratory muscle strength [ Time Frame: on study day 1 and the change from day 2 and day 3 ]
    Maximum inhalation and exhalation pressure

  • Body Composition [ Time Frame: on study day 1 and the change from day 2 and day 3 ]
    Body composition as measured by Dual-Energy X-ray Absorptiometry on study day 1 and the change from day 2 and day 3

  • Gut function [ Time Frame: postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on day 1 and the change from day 2 and day 3 ]
    Digestion of the stable tracers of amino acid


Estimated Enrollment: 100
Study Start Date: May 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: obese

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

Detailed Description:

The overarching hypothesis is that there are baseline, pre- and post-diet combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the very low calorie (VLC) diet.

In order to address the general hypothesis the following specific aims will be addressed:

Specific Aim 1: To test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects.

Specific Aim 2: To test the hypothesis that variation in % weight loss to the 2-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.

Specific Aim 3: To test the hypothesis that variation in % weight loss to the 4-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria obese subjects:

Diagnosed with morbid obesity (defined as BMI > 40 kg/m2 or BMI > 35 kg/m2 with at least one serious comorbidity (2013 NIH compendium guidelines)) Scheduled for medically supervised Very Low Calorie Diet Age 30 years and older Ability to lay in supine or elevated position for 5 hours Willingness and ability to comply with the protocol Exclusion Criteria Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only) Participation in Weight Loss Management Program within the last 6 months prior the first study day Presence of fever within the last 3 days Untreated metabolic diseases including hepatic or renal disorder unrelated to the primary disease Presence of acute illness or metabolically unstable chronic illness unrelated to the primary disease

· (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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780206


Locations
United States, Texas
Texas A&M University-CTRAL
College Station, Texas, United States, 77843
Sponsors and Collaborators
Texas A&M University
Investigators
Principal Investigator: Marielle Engelen Texas A&M University
  More Information

Responsible Party: Marielle PKJ Engelen, PhD, Associate Professor, Texas A&M University
ClinicalTrials.gov Identifier: NCT02780206     History of Changes
Other Study ID Numbers: IRB2016-0304
First Submitted: May 19, 2016
First Posted: May 23, 2016
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms