Clinical trial NCT02780206: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Very Low Calorie Diet
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in net whole-body protein synthesis
timeFrame: 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:
measure: Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Executive Function-Adolescent/Adult Sensory Profile (ASP)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in quality of life as measured by Short Form (36) Health Survey (SF36)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in state of mood as measured by the Profile of Mood State (POMS)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in attention and executive functions as measured by PASAT
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in attention and executive functions as measured by Trail Making Test (TMT)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Group differences in attention and executive functions as measured by Brief-A
timeFrame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3
measure: Skeletal muscle strength
timeFrame: on study day 1 and the change from day 2 and day 3
measure: 24 hour diet recall
timeFrame: on study day 1 and the change from day 2 and day 3
measure: Respiratory muscle strength
timeFrame: on study day 1 and the change from day 2 and day 3
measure: Body Composition
timeFrame: on study day 1 and the change from day 2 and day 3
measure: Gut function
timeFrame: 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
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M University-CTRAL
state: Texas
Study officials:
affiliation: Texas A&M University
name: Marielle Engelen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.