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ObesityFABNCT04577547

Food, Activity and Behavior Study

A study testing DGA diet WL & exercise, DGA diet WL & no exercise and DGA diet WM & exercise in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
DGA diet WL & exercise, DGA diet WL & no exercise and DGA diet WM & exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2024to Dec 2029
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Taking chronic anti-inflammatory medications
  • Being pregnant, lactating, or planning to become pregnant
  • Diagnosed eating disorder
  • Taking weight loss medication
  • Smoking
  • Overt hypothyroidism
Show all 13Show fewer
  • 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

About this study

Official title: Efficacy of the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans for Weight Control

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.

Read the 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.

Conditions
Obesity
Being tested
DGA diet WL & exercise, DGA diet WL & no exercise, DGA diet WM & exercise, DGA diet WM & no exercise, Western diet WL & exercise
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DGA diet WL & exerciseOther

    Intake of DGA weight loss 8 day rotating menu \& PAGA-recommended exercise

  • DGA diet WL & no exerciseOther

    Intake of DGA weight loss 8 day rotating menu \& no exercise

  • DGA diet WM & exerciseOther

    Intake of DGA weight maintenance 8 day rotating menu \& PAGA-recommended exercise

  • DGA diet WM & no exerciseOther

    Intake of DGA weight maintenance 8 day rotating menu \& no exercise

  • Western diet WL & exerciseOther

    Intake of Western-type weight loss 8 day rotating menu \& PAGA-recommended exercise

  • Western diet WL & no exerciseOther

    Intake of Western-type weight loss 8 day rotating menu \& no exercise

  • Western diet WM & exerciseOther

    Intake of Western-type weight maintenance 8 day rotating menu \& PAGA-recommended exercise

  • Western diet WM & no exerciseOther

    Intake of Western-type weight maintenance 8 day rotating menu \& no exercise

Study groups in NCT04577547
Study groupRoleWhat they receive
Dietary Guidelines (DGA) diet with weight loss (WL) & exerciseExperimentalMenu to provide DGA-recommended food group amounts at a calorie level to promote weight loss with Physical Activity Guidelines for Americans (PAGA)-recommended exercise
Receives: Other: DGA diet WL & exercise
DGA diet with WL & no exerciseExperimentalMenu to provide DGA-recommended food group amounts at a calorie level to promote weight loss with no exercise
Receives: Other: DGA diet WL & no exercise
DGA diet weight maintenance (WM) & exerciseExperimentalMenu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with PAGA-recommended exercise
Receives: Other: DGA diet WM & exercise
DGA diet WM & no exerciseExperimentalMenu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with no exercise
Receives: Other: DGA diet WM & no exercise
Western diet with WL & exerciseExperimentalWestern-type menu to provide a calorie level to promote weight loss with PAGA-recommended exercise
Receives: Other: Western diet WL & exercise
Western diet with WL & no exerciseExperimentalWestern-type menu to provide a calorie level to promote weight loss with no exercise
Receives: Other: Western diet WL & no exercise
Western diet WM exerciseExperimentalWestern-type menu to provide a calorie level to promote weight maintenance with PAGA-recommended exercise
Receives: Other: Western diet WM & exercise
Western diet WM no exerciseExperimentalWestern-type menu to provide a calorie level to promote weight maintenance with no exercise
Receives: Other: Western diet WM & no exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in C-reactive protein (CRP)

    The effect of diet and exercise on CRP

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

  2. 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).

    Measured: Weeks 0,12, 24

  3. 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).

    Measured: Weeks 0,12, 24

  4. 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

    Measured: Weeks 0,12

Secondary outcomes (12)

  1. 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.

    Measured: Weeks 0, 12, 24

  2. 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.

    Measured: Weeks 0, 12, 24

  3. 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.

    Measured: Weeks 0, 12, 24

  4. 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)

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

  5. Change in adipokines

    The effect of diet and exercise on plasma adipokines (e.g., adiponectin, resistin)

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

  6. Change in myokines

    The effect of diet and exercise on plasma myokines (e.g., BDNF, Myostatin, FGF-21, Irisin)

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

  7. 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)

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

  8. Change in blood lipids

    The effect of diet and exercise on cholesterol, HDL, triglycerides

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

  9. 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

    Measured: Weeks 0,12, 24

  10. Change in humoral biomarkers of eating behavior

    The effect of diet and exercise on ghrelin, leptin, thyroid hormones, gut peptides, fatty acids

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

  11. 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)

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

  12. 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)

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study startOct 2024 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Why it stopped: Never started

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04577547
Sponsor's protocol ID
GFHNRC512
Acronym
FAB
Status last verified
Jan 2023
First submitted
18 Jun 2020
Last updated
11 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DGA diet WL & exercise, DGA diet WL & no exercise and DGA diet WM & exercise in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in C-reactive protein (CRP) (time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04577547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.

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