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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04577547
Other study ID # GFHNRC512
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2024
Est. completion date December 2029

Study information

Verified date January 2023
Source USDA Grand Forks Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to test the effects of the Dietary and Physical Activity Guidelines for Americans on health and on eating and exercise behaviors.


Description:

The Dietary Guidelines for Americans (DGA), which include the Physical Activity Guidelines for Americans (PAGA), is the primary United States (U.S) government resource for weight control. The researchers propose that chronic, low grade inflammation (CLGI) limits weight control by acting upon physiological and behavioral factors that moderate weight control. Diet and exercise reduce CLGI and provide weight control, but no one has investigated the efficacy of the DGA and PAGA to reduce CLGI, whether reduced CLGI promotes greater weight control, and the moderating roles of physiological and behavioral factors on the association of reduced CLGI with weight control. To accomplish this, the researchers will conduct a 6-month trial in 224 obese adults; a 3-month controlled feeding trial with four dietary arms; 1) DGA with weight loss, 2) Western diet with weight loss,3) DGA diet weight maintenance, 4) Western diet weight maintenance. Each dietary arm will have PAGA-recommended exercise and non-exercise arms. Post-trial is a 3-month weight maintenance period. The primary outcome is change in C-reactive protein (CRP), a marker of CLGI. The results will inform the DGA and PAGA; thereby helping clinicians, public health workers, and policymakers to improve the health of Americans.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2029
Est. primary completion date December 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Obese (BMI 30.0 kg/m2 - 350 lbs [maximum weight for dual energy x-ray absorptiometry (DXA) machine]) - No contraindications to participate in exercise - hs-CRP level =3.0 and =10.0 mg/L or two consecutive measures of >10.0 mg/L measured two weeks apart - Access to high-speed internet Exclusion Criteria: - Taking chronic anti-inflammatory medications - Being pregnant, lactating, or planning to become pregnant - Diagnosed eating disorder - Taking weight loss medication - Smoking - Overt hypothyroidism - Cancer - Physical conditions that prevent safe exercise - Liking of <3 out of 10 for all available physical activity modes - Currently exercising for more than 30 minutes per day >3 days per week - Unwilling to continue with current exercise routine - Not willing to comply with all study requirements - Blood pressure greater than 140/90

Study Design


Related Conditions & MeSH terms


Intervention

Other:
DGA diet WL & exercise
Intake of DGA weight loss 8 day rotating menu & PAGA-recommended exercise
DGA diet WL & no exercise
Intake of DGA weight loss 8 day rotating menu & no exercise
DGA diet WM & exercise
Intake of DGA weight maintenance 8 day rotating menu & PAGA-recommended exercise
DGA diet WM & no exercise
Intake of DGA weight maintenance 8 day rotating menu & no exercise
Western diet WL & exercise
Intake of Western-type weight loss 8 day rotating menu & PAGA-recommended exercise
Western diet WL & no exercise
Intake of Western-type weight loss 8 day rotating menu & no exercise
Western diet WM & exercise
Intake of Western-type weight maintenance 8 day rotating menu & PAGA-recommended exercise
Western diet WM & no exercise
Intake of Western-type weight maintenance 8 day rotating menu & no exercise

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
USDA Grand Forks Human Nutrition Research Center

Outcome

Type Measure Description Time frame Safety issue
Other Single nucleotide polymorphisms (SNP) Correlation of SNPs associated with skeletal muscle, catecholamine, executive function and food and exercise reinforcement Weeks 0
Other micro RNA (miRNA) Correlation of miRNAs associated with skeletal muscle, executive function and food and exercise reinforcement Weeks 0, 12, 24
Primary Change in C-reactive protein (CRP) The effect of diet and exercise on CRP Weeks 0, 2, 4, 6, 8, 10, 12, 24
Primary Relative reinforcing value (RRV) of energy-dense snack foods 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). Weeks 0,12, 24
Primary Relative reinforcing value (RRV) of exercise 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). Weeks 0,12, 24
Primary Fat and carbohydrate oxidation The effect of diet and exercise on carbohydrate and fat oxidation in response to meals and exercise as measured by whole-room calorimetry Weeks 0,12
Secondary Food Cognitive Interference The effect of diet and exercise on food cognitive interference, one of the three cognitive domains of executive function, using a computerized Food Stroop test. Weeks 0, 12, 24
Secondary Cognitive flexibility The 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. Weeks 0, 12, 24
Secondary Working memory The effect of diet and exercise on cognitive flexibility, one of the three cognitive domains of executive function, using the Wisconsin Card Sorting Task. Weeks 0, 12, 24
Secondary Inflammation The 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) Weeks 0, 2, 4, 6, 8, 10, 12, 24
Secondary Change in adipokines The effect of diet and exercise on plasma adipokines (e.g., adiponectin, resistin) Weeks 0, 2, 4, 6, 8, 10, 12, 24
Secondary Change in myokines The effect of diet and exercise on plasma myokines (e.g., BDNF, Myostatin, FGF-21, Irisin) Weeks 0, 2, 4, 6, 8, 10, 12, 24
Secondary Change in bile acids The effect of diet and exercise on plasma bile acids (i.e., glycocholic acid, glyco-CDCA, glyco-HDCA, hyocholic acid, hyodeoxycholic acid) Weeks 0, 2, 4, 6, 8, 10, 12, 24
Secondary Change in blood lipids The effect of diet and exercise on cholesterol, HDL, triglycerides Weeks 0, 2, 4, 6, 8, 10, 12, 24
Secondary Change in weight control moderators 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 Weeks 0,12, 24
Secondary Change in humoral biomarkers of eating behavior The effect of diet and exercise on ghrelin, leptin, thyroid hormones, gut peptides, fatty acids Weeks 0, 2, 4, 6, 8, 10, 12, 24
Secondary Gene expression profiles of glucose oxidation 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) Weeks 0, 2, 4, 6, 8, 10, 12, 24
Secondary Gene expression profiles of fat oxidation 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) Weeks 0, 2, 4, 6, 8, 10, 12, 24
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