AzTrials
AzTrials

Healthy VolunteersNCT02199483

Metabolic and Neural Adaptations to Weight Loss, Plateau, and Regain

An observational study of Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Background: Many people can lose weight by changing their diet or exercise. However, most people eventually regain the weight over time. This weight regain may be related to changes in metabolism as well as changes in the brain caused by weight loss. Researchers want to learn more about these changes. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
How many people
0 participants
Where
No sites listed yet
Study dates
21 Jul 2014to 29 Jun 2017
Phase
Observational
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-55 years, male and female
  • Recent weight stability (< plus and minus 2 % over past 1 month)
  • Body mass index (BMI) greater than or equal to 30 kg/m2
  • Able to complete daily bouts of moderate to vigorous exercise (when applicable)
  • Written informed consent
  • Have reserved a stay of at least 4 weeks at The Biggest Loser Resort or have enrolled in a structured meal replacement weight loss program at the Washington Center for Weight Management and Research, the National Center for Weight and Wellness, or the Johns Hopkins Weight Management Center.

Who cannot join

  • Body weight > 400 lbs (weight limit of PET and MRI scanners)
  • BMI < 30 kg/m2
  • Less than 80% of maximum lifetime weight
  • Hypertension if
  • (1) >160/100;
  • (2) 140/90 to 159/99 with evidence of target organ damage (e.g. elevated serum creatinine, proteinuria, abnormal EKG, retinopathy);
Show all 22Show fewer
  • (3) >140/90 on antihypertensive medications.
  • Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease)
  • Past or present history of eating disorder (including binge eating) or psychiatric disease
  • Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
  • Hematocrit < 34% (women only)
  • Hematocrit < 40% (men only)
  • Pregnancy, lactation (women only)
  • Women who become pregnant during the two-year study period
  • Recent participation in a regular exercise program (> 4h/week of vigorous activity)
  • Previous bariatric surgery
  • Caffeine consumption > 500 mg/day
  • Regular use of alcohol (>2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months
  • Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, multiple food allergies)
  • Having metal implants incompatible with MRI (for example, pacemakers, metallic prostheses such as cochlear implants or heart valves, shrapnel fragments, etc.).
  • Non-native English speakers
  • Volunteers unwilling or unable to give informed consent

About this study

Background:

  • Many people can lose weight by changing their diet or exercise. However, most people eventually regain the weight over time. This weight regain may be related to changes in metabolism as well as changes in the brain caused by weight loss. Researchers want to learn more about these changes.
Read more

Objective:

  • To see how weight loss and regain affects the body s metabolism and the brain of obese but healthy adults.

Eligibility:

  • Obese but healthy adults age 18-55 who plan to participate in a weight loss program at one of several participating clinics or resorts.

Design:

  • Participants will first be screened at home through questionnaires and telephone interviews.
  • Participants will then be screened at the NIH with blood tests, medical history, physical exam, electrocardiograms, and questionnaires. They will have a mock magnetic resonance imaging (MRI) scan.
  • At visit 1, participants will stay at the NIH and will:
  • have MRI and PET brain scans.
  • have body composition scans and measurements.
  • give blood samples.
  • eat a special diet.
  • wear a physical activity monitor.
  • provide a urine sample and body weight daily.
  • drink a special type of water to measure calorie burn.
  • wear a clear plastic hood over their head while lying down, to collect exhaled air.
  • spend 24 hours in a room that measures oxygen and carbon dioxide.
  • complete questionnaires and computer tasks.
  • After visit 1, participants will give daily urine samples and weight and physical activity measurements from home. Then they will follow a lifestyle intervention for weight loss and give daily weight and activity measurements.
  • Visits 2, 3, and 4 occur 1-26 months after the start of the weight loss program. Participants will repeat procedures from visit 1. Visits 1-4 last 4 days each.
  • Researchers will track participants weight and physical activity for up to 26 months after visit 2.
Read the detailed description

Lifestyle interventions can result in weight loss, but most people experience a plateau after 6-10 months when weight stabilizes and many subsequently regain weight over the subsequent months. This pattern of weight plateau and regain is typical and appears to be independent of the lifestyle intervention used. The apparent resistance to further weight loss in not well understood.

We recently demonstrated that participants engaged in an intensive intervention employing caloric restriction and vigorous exercise had a profound slowing of metabolism that was significantly greater than expected due to weight loss alone. This phenomenon is called metabolic adaptation and has also been observed following weight loss through caloric restriction without exercise and may persist long after weight loss has ceased. Metabolic adaptation has been hypothesized to limit weight loss and predispose individuals to weight regain, but this has yet to be demonstrated and the concept is controversial. In addition to the metabolic adaptations to weight loss, the brain also adapts in ways that enhance the activation of reward regions in response to palatable food cues and their receipt. In particular, the brain s dopamine circuitry is believed to be altered in obesity and it is presently unclear how this pathway responds to a weight loss intervention in humans.

The primary aims of this study are to investigate the metabolic and neural adaptations in 60 obese adult volunteers participating in lifestyle interventions resulting in weight loss through a structured meal replacement program or caloric restriction plus vigorous exercise. The secondary aim is to determine whether the magnitude of metabolic adaptation or the changes in the brain s reward circuitry or responsiveness to food cues are related to the ubiquitous weight loss plateau after 6-10 months or the rate of weight regain in the subsequent months.

Keywords
Energy Expenditure, Behavioral Weight Loss Treatment, Neurocognitive Function, Weight Loss
Medical subject headings
Weight Loss

What is being measured

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

  1. To measure metabolic and neural adaptations after 4-12 weeks, 6-10 months, and 22-26 months following the start of a lifestyle intervention resulting in weight loss.

    Measured: ongoing

Secondary outcomes (2)

  1. To determine whether the degree of metabolic or neural adaptation at 4-12 weeks is correlated with the weight plateau at 6-10 months or the rate of weight regain in the subsequent months.

    Measured: ongoing

  2. To investigate changes in circulating hormone and metabolites that correlate with metabolic and neural adaptations as well as changes in appetitive behaviors following a lifestyle intervention resulting in weight loss.

    Measured: ongoing

Timeline

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

  1. First posted24 Jul 2014 (estimated)
  2. Study start21 Jul 2014
  3. Primary completion29 Jun 2017
  4. Study completion29 Jun 2017

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02199483
Sponsor's protocol ID
140154
Other IDs
14-DK-0154
Status last verified
29 Jun 2017
First submitted
23 Jul 2014
Last updated
12 Dec 2019
Results posted
No

Publications

  • Franz MJ, VanWormer JJ, Crain AL, Boucher JL, Histon T, Caplan W, Bowman JD, Pronk NP. Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up. J Am Diet Assoc. 2007 Oct;107(10):1755-67. doi: 10.1016/j.jada.2007.07.017.

    PubMed 17904936

  • Arone LJ, Mackintosh R, Rosenbaum M, Leibel RL, Hirsch J. Autonomic nervous system activity in weight gain and weight loss. Am J Physiol. 1995 Jul;269(1 Pt 2):R222-5. doi: 10.1152/ajpregu.1995.269.1.R222.

    PubMed 7631897

  • Johannsen DL, Knuth ND, Huizenga R, Rood JC, Ravussin E, Hall KD. Metabolic slowing with massive weight loss despite preservation of fat-free mass. J Clin Endocrinol Metab. 2012 Jul;97(7):2489-96. doi: 10.1210/jc.2012-1444. Epub 2012 Apr 24.

    PubMed 22535969

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

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 6 inclusion and 22 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 12 Dec 2019. 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?

To measure metabolic and neural adaptations after 4-12 weeks, 6-10 months, and 22-26 months following the start of a lifestyle intervention resulting in weight loss. (time frame: ongoing). 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 NCT02199483, which also lists 3 linked publications.

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 12 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in