Very Low Calorie Diet Weight Loss

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stable isotope amino acid infusion

About this trial

This is an interventional supportive care trial for Obesity

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Texas A&M University-CTRAL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

obese

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in net whole-body protein synthesis

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)

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)

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)

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)

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)

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)

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)

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)

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

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)

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)

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

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

handgrip and kin-com 1-leg test

24 hour diet recall

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

Maximum inhalation and exhalation pressure

Body Composition

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

Digestion of the stable tracers of amino acid

Full Information

NCT ID

NCT02780206

First Posted

May 19, 2016

Last Updated

February 3, 2022

Sponsor

Texas A&M University

1. Study Identification

Unique Protocol Identification Number

NCT02780206

Brief Title

Very Low Calorie Diet Weight Loss

Official Title

Omics Profiling of the Response to Food and Variability of Weight Loss in Medically Supervised Very Low Calorie Diet

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas A&M University

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Very Low Calorie Diet

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

obese

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Stable isotope amino acid infusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in net whole-body protein synthesis

Description

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

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

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame