Food, Activity and Behavior Study
- Conditions
- Obesity
- Interventions
- Other: DGA diet WL & no exerciseOther: Western diet WL & exerciseOther: Western diet WM & exerciseOther: DGA diet WM & no exerciseOther: Western diet WL & no exerciseOther: DGA diet WM & exerciseOther: DGA diet WL & exerciseOther: Western diet WM & no exercise
- Registration Number
- NCT04577547
- Lead Sponsor
- USDA Grand Forks Human Nutrition Research Center
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description DGA diet with WL & no exercise DGA diet WL & no exercise Menu to provide DGA-recommended food group amounts at a calorie level to promote weight loss with no exercise Western diet with WL & exercise Western diet WL & exercise Western-type menu to provide a calorie level to promote weight loss with PAGA-recommended exercise Western diet WM exercise Western diet WM & exercise Western-type menu to provide a calorie level to promote weight maintenance with PAGA-recommended exercise DGA diet WM & no exercise DGA diet WM & no exercise Menu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with no exercise Western diet with WL & no exercise Western diet WL & no exercise Western-type menu to provide a calorie level to promote weight loss with no exercise DGA diet weight maintenance (WM) & exercise DGA diet WM & exercise Menu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with PAGA-recommended exercise Dietary Guidelines (DGA) diet with weight loss (WL) & exercise DGA diet WL & exercise Menu to provide DGA-recommended food group amounts at a calorie level to promote weight loss with Physical Activity Guidelines for Americans (PAGA)-recommended exercise Western diet WM no exercise Western diet WM & no exercise Western-type menu to provide a calorie level to promote weight maintenance with no exercise
- Primary Outcome Measures
Name Time Method Relative reinforcing value (RRV) of exercise Weeks 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).
Fat and carbohydrate oxidation Weeks 0,12 The effect of diet and exercise on carbohydrate and fat oxidation in response to meals and exercise as measured by whole-room calorimetry
Change in C-reactive protein (CRP) Weeks 0, 2, 4, 6, 8, 10, 12, 24 The effect of diet and exercise on CRP
Relative reinforcing value (RRV) of energy-dense snack foods Weeks 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).
- Secondary Outcome Measures
Name Time Method Cognitive flexibility Weeks 0, 12, 24 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.
Change in weight control moderators Weeks 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
Change in humoral biomarkers of eating behavior Weeks 0, 2, 4, 6, 8, 10, 12, 24 The effect of diet and exercise on ghrelin, leptin, thyroid hormones, gut peptides, fatty acids
Change in myokines Weeks 0, 2, 4, 6, 8, 10, 12, 24 The effect of diet and exercise on plasma myokines (e.g., BDNF, Myostatin, FGF-21, Irisin)
Food Cognitive Interference Weeks 0, 12, 24 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.
Inflammation Weeks 0, 2, 4, 6, 8, 10, 12, 24 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)
Change in adipokines Weeks 0, 2, 4, 6, 8, 10, 12, 24 The effect of diet and exercise on plasma adipokines (e.g., adiponectin, resistin)
Change in bile acids Weeks 0, 2, 4, 6, 8, 10, 12, 24 The effect of diet and exercise on plasma bile acids (i.e., glycocholic acid, glyco-CDCA, glyco-HDCA, hyocholic acid, hyodeoxycholic acid)
Change in blood lipids Weeks 0, 2, 4, 6, 8, 10, 12, 24 The effect of diet and exercise on cholesterol, HDL, triglycerides
Gene expression profiles of glucose oxidation Weeks 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)
Working memory Weeks 0, 12, 24 The effect of diet and exercise on cognitive flexibility, one of the three cognitive domains of executive function, using the Wisconsin Card Sorting Task.
Gene expression profiles of fat oxidation Weeks 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)