Clinical trial NCT04577547: Food, Activity and Behavior Study
Official title: Efficacy of the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans for Weight Control
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2020-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in C-reactive protein (CRP)
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
measure: Relative reinforcing value (RRV) of energy-dense snack foods
timeFrame: Weeks 0,12, 24
measure: Relative reinforcing value (RRV) of exercise
timeFrame: Weeks 0,12, 24
measure: Fat and carbohydrate oxidation
timeFrame: Weeks 0,12
Secondary outcomes:
measure: Food Cognitive Interference
timeFrame: Weeks 0, 12, 24
measure: Cognitive flexibility
timeFrame: Weeks 0, 12, 24
measure: Working memory
timeFrame: Weeks 0, 12, 24
measure: Inflammation
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
measure: Change in adipokines
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
measure: Change in myokines
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
measure: Change in bile acids
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
measure: Change in blood lipids
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
measure: Change in weight control moderators
timeFrame: Weeks 0,12, 24
measure: Change in humoral biomarkers of eating behavior
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
measure: Gene expression profiles of glucose oxidation
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
measure: Gene expression profiles of fat oxidation
timeFrame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
Other outcomes:
measure: Single nucleotide polymorphisms (SNP)
timeFrame: Weeks 0
measure: micro RNA (miRNA)
timeFrame: Weeks 0, 12, 24
Locations:
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Shanon Casperson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References: