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Trial · NCT04577547

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in C-reactive protein (CRP)Weeks 0, 2, 4, 6, 8, 10, 12, 24The effect of diet and exercise on CRP
PrimaryRelative reinforcing value (RRV) of energy-dense snack foodsWeeks 0,12, 24
The effect of consuming a healthy DGA style or a Western style diet during weight loss and weight maintenance on the RRV of energy-dense snack food using a computer choice paradigm. For the computer choice paradigm subjects click the mouse button to play a simulated slot machine games to earn points toward receiving a portion of food or being able to do a non-food related sedentary activity (e.g., watching TV).
PrimaryRelative reinforcing value (RRV) of exerciseWeeks 0,12, 24
The effect of achieving the DGA recommended amounts of exercise during weight loss and weight maintenance on relative reinforcing value of exercise compared to a sedentary activity alternative using a computer choice paradigm. For the computer choice paradigm subjects click the mouse button to play a simulated slot machine games to earn points toward being able to do a chosen physical activity, such as walking on a treadmill, or a sedentary activity (e.g., watching TV).
PrimaryFat and carbohydrate oxidationWeeks 0,12The effect of diet and exercise on carbohydrate and fat oxidation in response to meals and exercise as measured by whole-room calorimetry
SecondaryFood Cognitive InterferenceWeeks 0, 12, 24The effect of diet and exercise on food cognitive interference, one of the three cognitive domains of executive function, using a computerized Food Stroop test.
SecondaryCognitive flexibilityWeeks 0, 12, 24The effect of diet and exercise on cognitive flexibility, one of the three cognitive domains of executive function, using a computerized Trail-Making test B/A.
SecondaryWorking memoryWeeks 0, 12, 24The effect of diet and exercise on cognitive flexibility, one of the three cognitive domains of executive function, using the Wisconsin Card Sorting Task.
SecondaryInflammationWeeks 0, 2, 4, 6, 8, 10, 12, 24The effect of diet and exercise on plasma pro-inflammatory cytokines (e.g., Il-6, MCP-1, TNF-alpha) and anti-inflammatory cytokines (e.g., IL-10, Soluble TNF receptor I and II)
SecondaryChange in adipokinesWeeks 0, 2, 4, 6, 8, 10, 12, 24The effect of diet and exercise on plasma adipokines (e.g., adiponectin, resistin)
SecondaryChange in myokinesWeeks 0, 2, 4, 6, 8, 10, 12, 24The effect of diet and exercise on plasma myokines (e.g., BDNF, Myostatin, FGF-21, Irisin)
SecondaryChange in bile acidsWeeks 0, 2, 4, 6, 8, 10, 12, 24The effect of diet and exercise on plasma bile acids (i.e., glycocholic acid, glyco-CDCA, glyco-HDCA, hyocholic acid, hyodeoxycholic acid)
SecondaryChange in blood lipidsWeeks 0, 2, 4, 6, 8, 10, 12, 24The effect of diet and exercise on cholesterol, HDL, triglycerides
SecondaryChange in weight control moderatorsWeeks 0,12, 24
Questionnaires (i.e., three-factor eating questionnaire, reward base eating, food attitudes and behavior survey) that when scored provide a single number will be used to determine the moderating effect of self efficacy, restraint and disinhibition maintaining diet and exercise changes
SecondaryChange in humoral biomarkers of eating behaviorWeeks 0, 2, 4, 6, 8, 10, 12, 24The effect of diet and exercise on ghrelin, leptin, thyroid hormones, gut peptides, fatty acids
SecondaryGene expression profiles of glucose oxidationWeeks 0, 2, 4, 6, 8, 10, 12, 24
The effect of diet and exercise on gene expression profiles associated with glucose oxidation (i.e., hexokinase, phosphofructokinase, pyruvate dehydrogenase kinase 4, peroxisome proliferator-activated receptor alpha gene expression)
SecondaryGene expression profiles of fat oxidationWeeks 0, 2, 4, 6, 8, 10, 12, 24
The effect of diet and exercise on on gene expression profiles associated with fat oxidation (i.e., fatty acid translocase, fatty acid synthase, acetyl Co-A carboxylase 2, stearoyl Co-A desaturase gene expression)
OtherSingle nucleotide polymorphisms (SNP)Weeks 0Correlation of SNPs associated with skeletal muscle, catecholamine, executive function and food and exercise reinforcement
Othermicro RNA (miRNA)Weeks 0, 12, 24Correlation of miRNAs associated with skeletal muscle, executive function and food and exercise reinforcement

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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