Very Low Calorie Diet Weight Loss
NCT02780206, Not applicable, Completed, Texas A&M University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Very Low Calorie Diet Weight Loss | ClinicalTrials.gov |
| NCT number | NCT02780206 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 56 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Texas A&M University | ClinicalTrials.gov |
| Conditions | Obesity, Very Low Calorie Diet | ClinicalTrials.gov |
| Interventions | Stable isotope amino acid infusion | ClinicalTrials.gov |
| First posted | 2016-05-23 | ClinicalTrials.gov |
| Last updated | 2022-02-04 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in net whole-body protein synthesis | 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 | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | 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 | a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding. | ClinicalTrials.gov |
| Secondary | 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 | 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) | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | Group differences in state of mood as measured by the Profile of Mood State (POMS) | 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. | ClinicalTrials.gov |
| Secondary | Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT) | 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. | ClinicalTrials.gov |
| Secondary | Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT) | 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 | ClinicalTrials.gov |
| Secondary | Group differences in attention and executive functions as measured by PASAT | 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. | ClinicalTrials.gov |
| Secondary | Group differences in attention and executive functions as measured by Trail Making Test (TMT) | 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. | ClinicalTrials.gov |
| Secondary | Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA) | 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. | ClinicalTrials.gov |
| Secondary | Group differences in attention and executive functions as measured by Brief-A | 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. | ClinicalTrials.gov |
| Secondary | Skeletal muscle strength | on study day 1 and the change from day 2 and day 3 | handgrip and kin-com 1-leg test | ClinicalTrials.gov |
| Secondary | 24 hour diet recall | 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. | ClinicalTrials.gov |
| Secondary | Respiratory muscle strength | on study day 1 and the change from day 2 and day 3 | Maximum inhalation and exhalation pressure | ClinicalTrials.gov |
| Secondary | Body Composition | 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 | ClinicalTrials.gov |
| Secondary | Gut function | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)