Binge Eating DisorderNCT01552759
Appetite Hormones in Binge Eating Disorder
A study testing Postprandial responses, Cold pressor test and Test meal in people with Binge Eating Disorder, run by New York Obesity and Nutrition Research Center at 1 site in United States.
Trial summary
This study investigates the hormones that the body produces in response to food intake and in response to stress, and the way that stress influences food intake. In particular, it compares the hormone levels and food intake of people with and without binge eating disorder. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Postprandial responses, Cold pressor test and Test meal
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 20-25 or 30-50
- stable weight(± 4%) for at least 3 mo
- premenopausal and have regular menstrual cycles (28 d ± 5), not be pregnant or lactating, and not be within 1 y of childbirth
- must like pizza and be willing to consume it during the ad libitum meal
Who cannot join
- significant medical or psychiatric conditions
- current and past 3-mo use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (> 3 drinks/d)
- vigorously exercise for more than 6 h/wk
- left-handed, with known claustrophobia for a scanner enclosure, or have metal implants, non-removable metallic dental retainers, pacemakers, or permanent eyeliner or large tattoos that contain metallic pigment
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the hormones that the body produces in response to food intake and in response to stress, and the way that stress influences food intake. In particular, it compares the hormone levels and food intake of people with and without binge eating disorder. In order to find out how these appetite- and stress-related hormones are linked to brain activity, the study also includes an fMRI scan, a non-invasive procedure that looks at which regions of the brain are most active during a food-related scenario.
Read the detailed description
The objectives are to study appetite-related hormones regulating food intake under normal conditions and following a stressor in the morning and evening (when most binge episodes occur), to help reveal biological mechanisms in BED. We plan to enroll: 32 obese Ss with BED (16m, 16f), 32 obese Ss without BED (16m, 16f) and 32 normal-weight Ss without BED (16m, 16f). Height, weight, waist circumference, and body fat will be assessed during a first appointment. On two different days separated by at least a week, Ss will ingest a fixed liquid meal once in the morning and once in the evening. Appetite ratings and collections of blood and saliva to measure hormones will continue for 2 hours after the fixed meal. This will be followed on each day by a laboratory stress protocol (Socially Evaluated Cold Pressor Test; SECPT), and then consumption of an ad libitum meal 30 minutes later. On one day during the protocol, the participant will collect saliva using a swab immediately after waking and again at 08.00. In order to capture more naturalistic eating episodes, all Ss will additionally record food intake, rate appetite, and measure salivary cortisol before and after one evening meal, and one after-dinner snack (or after-dinner binge for BED Ss). On two additional days, we will use fMRI to assess brain activation in response to high-palatability food (HPF) relative to low-palatability food (LPF) or non-food (NF) visual cues following the SECPT and a control condition using warm water. On each day, following the fMRI scan, an ad libitum meal will be consumed.
- Conditions
- Binge Eating Disorder
- Being tested
- Postprandial responses, Cold pressor test, Test meal
- Keywords
- Appetite Hormones, Binge Eating Disorder, Obesity, Cortisol, Stress
- Medical subject headings
- Binge-Eating Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postprandial responsesProcedure or surgery
Also called Liquid meal replacement is Boost (Nestle Nutrition).
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Cold pressor testBehavioural
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Test mealBehavioural
Subjects are presented with an ad libitum buffet meal.
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects with BED | Experimental | Subjects who meet the BMI requirement for obesity (>30 kg/m^2) and the DSM requirements for binge eating disorder based on responses to validated questionnaires.
Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal. Receives: Procedure: Postprandial responses; Behavioral: Cold pressor test; Behavioral: Test meal |
| Obese without BED | Experimental | Subjects who meet the BMI requirement for obesity (>30 kg/m^2) but who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires.
Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal. Receives: Procedure: Postprandial responses; Behavioral: Cold pressor test; Behavioral: Test meal |
| Normal-weight without BED | Experimental | Subjects with BMI 20-25 kg/m^2 who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires.
Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal. Receives: Procedure: Postprandial responses; Behavioral: Cold pressor test; Behavioral: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test
Blood and saliva concentrations of hormones influencing appetite will be measured at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00. Appetite will additionally be rated at each assessment point. This will be followed by a cold pressor test, and then 30 min later by an ad libitum meal 30 min later, with blood and saliva measurements taken before and after completion of the meal.
Measured: Assessed at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00
Secondary outcomes (3)
Cortisol Awakening response
On one weekday morning during the 3-week participation period, participants will take one saliva measurement on awakening and at 08.00 while still fasting. Awakening and 08.00 cortisol levels are expected to be higher in BED compared with nonBED Ss, and in obese nonBED compared with normal-weight nonBED Ss.
Measured: Assessed on one weekday morning during the 3-week participation period
Psychological Scales
Various questionnaires will be administered to test relationships between outcomes (e.g., intake, hormone levels), and psychological constructs including depression, perceived stress, external and emotional eating and restraint, binge-eating behavior, and night eating. Outcomes will be correlated with scale scores, and scores will be compared between groups. Among other relationships, we anticipate positive correlations between binge eating score, ad libitum intake and ghrelin SECPT response. Psychological scores will be entered as covariates as appropriate.
Measured: During one initial consultation and on two subsequent visits at least 1 week apart
Body Weight, Body Composition and Gender
Measurements will include height, weight, waist circumference, total body fat from BIA, and cross-sectional abdominal MRI to estimate central, visceral, and subcutaneous fat. Each adiposity index will be correlated with outcomes and compared between groups.
Measured: During one initial consultation and on two subsequent visits at least 1 week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMay 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Obesity and Nutrition Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center, Columbia University
- Responsible party
- Principal investigator, Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
- Investigators
- Allan Geliebter, PhD, Principal investigator, New York Obesity and Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552759
- Sponsor's protocol ID
- 06-163
- Status last verified
- Mar 2013
- First submitted
- 9 Mar 2012
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Zwaan M, Mitchell JE, Raymond NC, Spitzer RL. Binge eating disorder: clinical features and treatment of a new diagnosis. Harv Rev Psychiatry. 1994 Mar-Apr;1(6):310-25. doi: 10.3109/10673229409017098.
PubMed 9384866Hellstrom PM, Geliebter A, Naslund E, Schmidt PT, Yahav EK, Hashim SA, Yeomans MR. Peripheral and central signals in the control of eating in normal, obese and binge-eating human subjects. Br J Nutr. 2004 Aug;92 Suppl 1:S47-57. doi: 10.1079/bjn20041142.
PubMed 15384323Cowley MA, Smith RG, Diano S, Tschop M, Pronchuk N, Grove KL, Strasburger CJ, Bidlingmaier M, Esterman M, Heiman ML, Garcia-Segura LM, Nillni EA, Mendez P, Low MJ, Sotonyi P, Friedman JM, Liu H, Pinto S, Colmers WF, Cone RD, Horvath TL. The distribution and mechanism of action of ghrelin in the CNS demonstrates a novel hypothalamic circuit regulating energy homeostasis. Neuron. 2003 Feb 20;37(4):649-61. doi: 10.1016/s0896-6273(03)00063-1.
PubMed 12597862Batterham RL, Cohen MA, Ellis SM, Le Roux CW, Withers DJ, Frost GS, Ghatei MA, Bloom SR. Inhibition of food intake in obese subjects by peptide YY3-36. N Engl J Med. 2003 Sep 4;349(10):941-8. doi: 10.1056/NEJMoa030204.
PubMed 12954742English PJ, Ghatei MA, Malik IA, Bloom SR, Wilding JP. Food fails to suppress ghrelin levels in obese humans. J Clin Endocrinol Metab. 2002 Jun;87(6):2984. doi: 10.1210/jcem.87.6.8738.
PubMed 12050284Monteleone P, Martiadis V, Rigamonti AE, Fabrazzo M, Giordani C, Muller EE, Maj M. Investigation of peptide YY and ghrelin responses to a test meal in bulimia nervosa. Biol Psychiatry. 2005 Apr 15;57(8):926-31. doi: 10.1016/j.biopsych.2005.01.004.
PubMed 15820714Monteleone P, Martiadis V, Fabrazzo M, Serritella C, Maj M. Ghrelin and leptin responses to food ingestion in bulimia nervosa: implications for binge-eating and compensatory behaviours. Psychol Med. 2003 Nov;33(8):1387-94. doi: 10.1017/s0033291703008316.
PubMed 14672247Geliebter A, Yahav EK, Gluck ME, Hashim SA. Gastric capacity, test meal intake, and appetitive hormones in binge eating disorder. Physiol Behav. 2004 Jul;81(5):735-40. doi: 10.1016/j.physbeh.2004.04.014.
PubMed 15234178Geliebter A, Gluck ME, Hashim SA. Plasma ghrelin concentrations are lower in binge-eating disorder. J Nutr. 2005 May;135(5):1326-30. doi: 10.1093/jn/135.5.1326.
PubMed 15867334Raymond NC, Neumeyer B, Warren CS, Lee SS, Peterson CB. Energy intake patterns in obese women with binge eating disorder. Obes Res. 2003 Jul;11(7):869-79. doi: 10.1038/oby.2003.120.
PubMed 12855757Walsh BT, Boudreau G. Laboratory studies of binge eating disorder. Int J Eat Disord. 2003;34 Suppl:S30-8. doi: 10.1002/eat.10203.
PubMed 12900984Anderson DA, Williamson DA, Johnson WG, Grieve CO. Validity of test meals for determining binge eating. Eat Behav. 2001 Summer;2(2):105-12. doi: 10.1016/s1471-0153(01)00022-8.
PubMed 15001040Geliebter A, Melton PM, McCray RS, Gallagher DR, Gage D, Hashim SA. Gastric capacity, gastric emptying, and test-meal intake in normal and bulimic women. Am J Clin Nutr. 1992 Oct;56(4):656-61. doi: 10.1093/ajcn/56.4.656.
PubMed 1414964Geliebter A, Hassid G, Hashim SA. Test meal intake in obese binge eaters in relation to mood and gender. Int J Eat Disord. 2001 May;29(4):488-94. doi: 10.1002/eat.1047.
PubMed 11285588Tataranni PA, Larson DE, Snitker S, Young JB, Flatt JP, Ravussin E. Effects of glucocorticoids on energy metabolism and food intake in humans. Am J Physiol. 1996 Aug;271(2 Pt 1):E317-25. doi: 10.1152/ajpendo.1996.271.2.E317.
PubMed 8770026
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite Hormones in Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT01552759
- Acronym / sponsor ID
- 06-163
- Conditions
- Binge Eating Disorder
- Keywords
- Appetite Hormones, Binge Eating Disorder, Obesity, Cortisol, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- New York Obesity and Nutrition Research CenterUniversity, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center, Columbia University
- Study start
- May 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the hormones that the body produces in response to food intake and in response to stress, and the way that stress influences food intake. In particular, it compares the hormone levels and food intake of people with and without binge eating disorder. In order to find out how these appetite- and stress-related hormones are linked to brain activity, the study also includes an fMRI scan, a non-invasive procedure that looks at which regions of the brain are most active during a food-related scenario.
Detailed description
The objectives are to study appetite-related hormones regulating food intake under normal conditions and following a stressor in the morning and evening (when most binge episodes occur), to help reveal biological mechanisms in BED. We plan to enroll: 32 obese Ss with BED (16m, 16f), 32 obese Ss without BED (16m, 16f) and 32 normal-weight Ss without BED (16m, 16f). Height, weight, waist circumference, and body fat will be assessed during a first appointment. On two different days separated by at least a week, Ss will ingest a fixed liquid meal once in the morning and once in the evening. Appetite ratings and collections of blood and saliva to measure hormones will continue for 2 hours after the fixed meal. This will be followed on each day by a laboratory stress protocol (Socially Evaluated Cold Pressor Test; SECPT), and then consumption of an ad libitum meal 30 minutes later. On one day during the protocol, the participant will collect saliva using a swab immediately after waking and again at 08.00. In order to capture more naturalistic eating episodes, all Ss will additionally record food intake, rate appetite, and measure salivary cortisol before and after one evening meal, and one after-dinner snack (or after-dinner binge for BED Ss). On two additional days, we will use fMRI to assess brain activation in response to high-palatability food (HPF) relative to low-palatability food (LPF) or non-food (NF) visual cues following the SECPT and a control condition using warm water. On each day, following the fMRI scan, an ad libitum meal will be consumed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese subjects with BED | Experimental | Procedure: Postprandial responses, Behavioral: Cold pressor test, Behavioral: Test mealSubjects who meet the BMI requirement for obesity (>30 kg/m^2) and the DSM requirements for binge eating disorder based on responses to validated questionnaires. Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal. |
| Obese without BED | Experimental | Procedure: Postprandial responses, Behavioral: Cold pressor test, Behavioral: Test mealSubjects who meet the BMI requirement for obesity (>30 kg/m^2) but who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires. Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal. |
| Normal-weight without BED | Experimental | Procedure: Postprandial responses, Behavioral: Cold pressor test, Behavioral: Test mealSubjects with BMI 20-25 kg/m^2 who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires. Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI of 20-25 or 30-50
- stable weight(± 4%) for at least 3 mo
- premenopausal and have regular menstrual cycles (28 d ± 5), not be pregnant or lactating, and not be within 1 y of childbirth
- must like pizza and be willing to consume it during the ad libitum meal
Key exclusion criteria (4 listed)
- significant medical or psychiatric conditions
- current and past 3-mo use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (> 3 drinks/d)
- vigorously exercise for more than 6 h/wk
- left-handed, with known claustrophobia for a scanner enclosure, or have metal implants, non-removable metallic dental retainers, pacemakers, or permanent eyeliner or large tattoos that contain metallic pigment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postprandial responsesAlso: Liquid meal replacement is Boost (Nestle Nutrition).Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal. | Procedure or surgery | Normal-weight without BED, Obese subjects with BED, Obese without BED |
| Cold pressor testSubjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test. | Behavioural | Normal-weight without BED, Obese subjects with BED, Obese without BED |
| Test mealSubjects are presented with an ad libitum buffet meal. | Behavioural | Normal-weight without BED, Obese subjects with BED, Obese without BED |
Primary outcome
Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test
Time frame: Assessed at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00
Blood and saliva concentrations of hormones influencing appetite will be measured at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00. Appetite will additionally be rated at each assessment point. This will be followed by a cold pressor test, and then 30 min later by an ad libitum meal 30 min later, with blood and saliva measurements taken before and after completion of the meal.
3 secondary outcomes
Cortisol Awakening response
Time frame: Assessed on one weekday morning during the 3-week participation period
Psychological Scales
Time frame: During one initial consultation and on two subsequent visits at least 1 week apart
Body Weight, Body Composition and Gender
Time frame: During one initial consultation and on two subsequent visits at least 1 week apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
- Background: PubMed 9384866de Zwaan M, Mitchell JE, Raymond NC, Spitzer RL. Binge eating disorder: clinical features and treatment of a new diagnosis. Harv Rev Psychiatry. 1994 Mar-Apr;1(6):310-25. doi: 10.3109/10673229409017098.
- Background: PubMed 15384323Hellstrom PM, Geliebter A, Naslund E, Schmidt PT, Yahav EK, Hashim SA, Yeomans MR. Peripheral and central signals in the control of eating in normal, obese and binge-eating human subjects. Br J Nutr. 2004 Aug;92 Suppl 1:S47-57. doi: 10.1079/bjn20041142.
- Background: PubMed 12597862Cowley MA, Smith RG, Diano S, Tschop M, Pronchuk N, Grove KL, Strasburger CJ, Bidlingmaier M, Esterman M, Heiman ML, Garcia-Segura LM, Nillni EA, Mendez P, Low MJ, Sotonyi P, Friedman JM, Liu H, Pinto S, Colmers WF, Cone RD, Horvath TL. The distribution and mechanism of action of ghrelin in the CNS demonstrates a novel hypothalamic circuit regulating energy homeostasis. Neuron. 2003 Feb 20;37(4):649-61. doi: 10.1016/s0896-6273(03)00063-1.
- Background: PubMed 12954742Batterham RL, Cohen MA, Ellis SM, Le Roux CW, Withers DJ, Frost GS, Ghatei MA, Bloom SR. Inhibition of food intake in obese subjects by peptide YY3-36. N Engl J Med. 2003 Sep 4;349(10):941-8. doi: 10.1056/NEJMoa030204.
- Background: PubMed 12050284English PJ, Ghatei MA, Malik IA, Bloom SR, Wilding JP. Food fails to suppress ghrelin levels in obese humans. J Clin Endocrinol Metab. 2002 Jun;87(6):2984. doi: 10.1210/jcem.87.6.8738.
- Background: PubMed 15820714Monteleone P, Martiadis V, Rigamonti AE, Fabrazzo M, Giordani C, Muller EE, Maj M. Investigation of peptide YY and ghrelin responses to a test meal in bulimia nervosa. Biol Psychiatry. 2005 Apr 15;57(8):926-31. doi: 10.1016/j.biopsych.2005.01.004.
- Background: PubMed 14672247Monteleone P, Martiadis V, Fabrazzo M, Serritella C, Maj M. Ghrelin and leptin responses to food ingestion in bulimia nervosa: implications for binge-eating and compensatory behaviours. Psychol Med. 2003 Nov;33(8):1387-94. doi: 10.1017/s0033291703008316.
- Background: PubMed 15234178Geliebter A, Yahav EK, Gluck ME, Hashim SA. Gastric capacity, test meal intake, and appetitive hormones in binge eating disorder. Physiol Behav. 2004 Jul;81(5):735-40. doi: 10.1016/j.physbeh.2004.04.014.
- Background: PubMed 15867334Geliebter A, Gluck ME, Hashim SA. Plasma ghrelin concentrations are lower in binge-eating disorder. J Nutr. 2005 May;135(5):1326-30. doi: 10.1093/jn/135.5.1326.
- Background: PubMed 12855757Raymond NC, Neumeyer B, Warren CS, Lee SS, Peterson CB. Energy intake patterns in obese women with binge eating disorder. Obes Res. 2003 Jul;11(7):869-79. doi: 10.1038/oby.2003.120.
- Background: PubMed 12900984Walsh BT, Boudreau G. Laboratory studies of binge eating disorder. Int J Eat Disord. 2003;34 Suppl:S30-8. doi: 10.1002/eat.10203.
- Background: PubMed 15001040Anderson DA, Williamson DA, Johnson WG, Grieve CO. Validity of test meals for determining binge eating. Eat Behav. 2001 Summer;2(2):105-12. doi: 10.1016/s1471-0153(01)00022-8.
- New York Obesity and Nutrition Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Geliebter, PhD principal investigator
New York Obesity and Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postprandial responses, Cold pressor test and Test meal in people with Binge Eating Disorder, run by New York Obesity and Nutrition Research Center at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test (time frame: Assessed at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00). 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 NCT01552759, which also lists 22 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 11 Mar 2013.