Eating BehaviorNCT03947281
Snacks and Satiety
A study testing Almond snack and Cereal-based snack in people with Eating Behavior and Overweight, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
This study is designed to compare two types of snacks (almonds or a cereal-based snack), eaten between meals, on measures of appetite, including appetitive hormones, self-reported feelings of hunger and fullness, and food intake at a buffet meal or in the home environment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Overweight, Obesity
- What is being tested?
- Almond snack and Cereal-based snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 8 Aug 2022
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal
- Body Mass Index 25 - 39.9 kg/m2
Who cannot join
- Women who are post-menopausal or peri-menopausal
- BMI < 25 or > 40 kg/m2
- Allergies to tree nuts
- Using any hormonal contraception including oral contraceptive, contraceptive patch, contraceptive ring, contraceptive injection (e.g. Depo-Provera), or contraceptive implant (e.g. Nexplanon/Implanon)
- Menstrual cycle lengths < 25 days or > 45 days, or have amenorrhea, eumenorrhea, or polymenorrhea.
- Pregnant or nursing within the last 6 months, or plan to become pregnant during the trial
- Medical diagnoses of chronic diseases including cardiovascular or pulmonary diseases, renal disease, cancer, type 1 or type 2 diabetes mellitus, thyroid disease requiring medication, inflammatory bowel disease, irritable bowel disease, or those with recent major surgeries
- current medical diagnosis of polycystic ovarian syndrome (PCOS).
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Almond Snacks and Satiety: a Randomized Intervention Trial Examining Acute and Chronic Effects
This study is designed to compare two types of snacks (almonds or a cereal-based snack), eaten between meals, on measures of appetite, including appetitive hormones, self-reported feelings of hunger and fullness, and food intake at a buffet meal or in the home environment. The investigators hypothesize that the acute responses of appetitive hormones to a meal challenge protocol will differ between almond and cereal-based snacks based on multivariate models of satiety that will be predictive of ad libitum food intake at a dinner meal as part of the meal challenge protocol. Further, the investigators will estimate if, under free-living conditions, self-selected and self-reported food intake will show appropriate energy compensation for the added calories of the snacks, and determine if one type of snack is superior to the other in this regard.
Read the detailed description
This study will use a randomized, parallel design that includes an almond snack intervention and a cereal-based snack intervention group. The almond intervention will be roasted, unsalted almonds at a level of 56 grams per day for 4 weeks. The cereal-based intervention will be isocaloric snacks provided in the form of a mixture of dry cereal, pretzels, and bread sticks for 4 weeks. A satiety test protocol will be done at the beginning and the end of the intervention period. Each test day will include measures of satiety responses to two standard meals, two snacks (either almonds or cereal-based snacks), and a dinner buffet. The protocol to evaluate satiety signals include tonic measures that may signal homeostasis to the brain and evaluation of episodic signals that may drive food intake In addition, other modulators of satiety will be tested including evaluation of preferences for palatable foods, self-reports of cravings and satiety using questionnaires, and perceived hunger, fullness, desire to eat.
- Conditions
- Eating Behavior, Overweight, Obesity
- Being tested
- Almond snack, Cereal-based snack
- Keywords
- satiety, gastrointestinal hormones, appetite, Dietary fiber, food cravings
- Medical subject headings
- Feeding Behavior, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond snackOther
The almond intervention will be roasted, unsalted almonds provided at 56 g/day for 28 days. Almonds provide approximately 350 kcals/day.
Cereal-based snackOther
The cereal-based intervention will be a prepared mix of cereal, pretzels, and bread sticks prepared at the WHNRC. It will be provided at the level of 350 kcals per day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Almond snack | Experimental | The almond intervention will be roasted almonds 56 grams/day for 28 days. The caloric value is approximately 350 kcals. Receives: Other: Almond snack |
| Cereal-based snack | Experimental | The cereal-based intervention will be a mixture of dry cereal, pretzels, and bread sticks prepared by the Western Human Nutrition Research Center (WHNRC). The caloric value is approximately 350 kcals. Receives: Other: Cereal-based snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline level and change in cholecystokinin
Cholecystokinin (CCK) measured in blood using an antibody based assay
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in peptide-YY
Peptide-YY (PYY) measured in blood using an antibody based assay
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in glucose-like peptide 1
Glucose-like peptide 1 (GLP-1) measured in blood using an antibody based assay
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in gastric inhibitory peptide
Gastric inhibitory peptide (GIP) measured in blood using an antibody based assay
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in insulin
Insulin measured in blood using an antibody based assay
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in glucose
Glucose measured by standard chemistry in blood
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in oleoylethanolamide
Oleoylethanolamide measured by mass spectrometry in blood
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in ghrelin
Ghrelin measured in blood using an antibody based assay
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in leptin
Leptin measured in blood using an antibody based assay
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in orexin
Orexin measured in blood using an antibody based assay
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in endocannabinoid profiles
Endocannabinoid profiles measured by mass spectrometry in blood
Measured: Baseline, 60 minutes before lunch meal, and 10, 30, and 150 minutes after a lunch meal
Baseline level and change in hunger
Self-reported feelings of hunger measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Measured: Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
Baseline level and change in satiety
Self-reported feelings of fullness measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Measured: Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
Change in food intake at a dinner meal
Calories consumed at a dinner meal following the satiety protocol
Measured: Week 1 and 4
Secondary outcomes (22)
Body composition reference measurement
Body composition (fat mass and fat-free mass in kg) will be measured once during the study using dual energy x-ray absorptiometry (DEXA)
Measured: Week 1
Change in body weight
measured in kg
Measured: Weeks 0, 1, 2, 3, and 4
Change in body fat
measured in kg using multi frequency bioimpedance
Measured: Weeks 0, 1, 2, 3, and 4
Change in lean body mass
measured in kg using multi frequency bioimpedance
Measured: Weeks 0, 1, 2, 3, and 4
Change in total body water
measured in kg using multi frequency bioimpedance
Measured: Weeks 0, 1, 2, 3, and 4
Change in waist circumference
measured in cm
Measured: Week 0 and 4
Change in hip circumference
measured in cm
Measured: Week 0 and 4
Change in Food Choice
Food choice computer-based tests from Leeds, United Kingdom, will be used to estimate explicit liking and implicit wanting for several different categories of foods.
Measured: Baseline and following a lunch meal at Weeks 0 and 4
Change in food craving
Food craving estimated from the questionnaire, Food Craving Inventory, on a 5 point likert scale
Measured: Week 0 and 4
Change in self-reported satiety
Self reported satiety measured using the 5-factor satiety questionnaire. Scale is a generalized labeled magnitude scale of 150 mm Subscales include mental hunger, physical hunger, mental fullness, physical fullness, and satiation. Subscale scores will range from 0 to 150.
Measured: Week 0 and 4
Power of food questionnaire
Power of food questionnaire measured once on a 5 point likert scale
Measured: Week 0
Food addiction questionnaire
Yale food addiction questionnaire measured once on a 5-point likert scale
Measured: Week 0
Eating behavior
Dutch eating behavior questionnaire measured once. Scale is a 5-point likert scale. Sub scales include restrained eating, emotional eating, and external eating. Scores will be reported separately for each subscale.
Measured: Week 0
Three factor eating inventory
Three factor eating inventory questionnaire measured once. Instrument has three subscales, combining likert scales and true/false questions. Subscales include cognitive restraint (score can range from 0 to 21), disinhibition (score can range from 0 to 16) and hunger (score can range from 0 to 14).
Measured: Week 0
Premenstrual Syndrome
Premenstrual Syndrome screening questionnaire measured once. Scale is a 4-point likert. Subscales for premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD), reported separately.
Measured: Week 0
General health and well-being
The SF-36 General Health and Well-being questionnaire measured once
Measured: Week 0
Usual physical activity
Physical activity estimated from the Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.
Measured: Week 0
Change in metabolic rate
Resting and post-prandial metabolic rate measured using indirect calorimetry.
Measured: Baseline and 1 hour before lunch meal, 1 hour after lunch meal, and 1 hour after mid-afternoon snack
Change in dietary intake
Dietary intake estimated from 24-hour recall using a web based automated multi-pass method
Measured: Ten dietary recalls collected at home during weeks 1-4
Genetic risk of obesity
A polygenic risk score (PRS) indexing genetic predisposition to obesity using known obesity single nucleotide polymorphisms (SNPs).
Measured: Week 1
Change in liver fat
Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®
Measured: Week 0 and 4
Change in liver stiffness
Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®
Measured: Week 0 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start24 Jun 2019
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Why it stopped: After delay due to pandemic, sponsor declined to continue funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomized, parallel design that includes an almond snack group and a cereal-based snack group. The intervention will be for 28 days. The almond intervention will be roasted almonds 56 grams/day. The cereal-based snack intervention will be the caloric equivalent.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947281
- Sponsor's protocol ID
- FL107
- Status last verified
- Oct 2024
- First submitted
- 9 May 2019
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almond Snacks and Satiety: a Randomized Intervention Trial Examining Acute and Chronic Effects
- ClinicalTrials.gov ID
- NCT03947281
- Acronym / sponsor ID
- FL107
- Conditions
- Eating Behavior, Overweight, Obesity
- Keywords
- satiety, gastrointestinal hormones, appetite, Dietary fiber, food cravings
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After delay due to pandemic, sponsor declined to continue funding.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- Almond Board of California
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 13 May 2019 (actual)
- 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 is designed to compare two types of snacks (almonds or a cereal-based snack), eaten between meals, on measures of appetite, including appetitive hormones, self-reported feelings of hunger and fullness, and food intake at a buffet meal or in the home environment. The investigators hypothesize that the acute responses of appetitive hormones to a meal challenge protocol will differ between almond and cereal-based snacks based on multivariate models of satiety that will be predictive of ad libitum food intake at a dinner meal as part of the meal challenge protocol. Further, the investigators will estimate if, under free-living conditions, self-selected and self-reported food intake will show appropriate energy compensation for the added calories of the snacks, and determine if one type of snack is superior to the other in this regard.
Detailed description
This study will use a randomized, parallel design that includes an almond snack intervention and a cereal-based snack intervention group. The almond intervention will be roasted, unsalted almonds at a level of 56 grams per day for 4 weeks. The cereal-based intervention will be isocaloric snacks provided in the form of a mixture of dry cereal, pretzels, and bread sticks for 4 weeks. A satiety test protocol will be done at the beginning and the end of the intervention period. Each test day will include measures of satiety responses to two standard meals, two snacks (either almonds or cereal-based snacks), and a dinner buffet. The protocol to evaluate satiety signals include tonic measures that may signal homeostasis to the brain and evaluation of episodic signals that may drive food intake In addition, other modulators of satiety will be tested including evaluation of preferences for palatable foods, self-reports of cravings and satiety using questionnaires, and perceived hunger, fullness, desire to eat.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a randomized, parallel design that includes an almond snack group and a cereal-based snack group. The intervention will be for 28 days. The almond intervention will be roasted almonds 56 grams/day. The cereal-based snack intervention will be the caloric equivalent.
| Arm | Type | Receives |
|---|---|---|
| Almond snack | Experimental | Other: Almond snackThe almond intervention will be roasted almonds 56 grams/day for 28 days. The caloric value is approximately 350 kcals. |
| Cereal-based snack | Experimental | Other: Cereal-based snackThe cereal-based intervention will be a mixture of dry cereal, pretzels, and bread sticks prepared by the Western Human Nutrition Research Center (WHNRC). The caloric value is approximately 350 kcals. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pre-menopausal
- Body Mass Index 25 - 39.9 kg/m2
Key exclusion criteria (8 listed)
- Women who are post-menopausal or peri-menopausal
- BMI < 25 or > 40 kg/m2
- Allergies to tree nuts
- Using any hormonal contraception including oral contraceptive, contraceptive patch, contraceptive ring, contraceptive injection (e.g. Depo-Provera), or contraceptive implant (e.g. Nexplanon/Implanon)
- Menstrual cycle lengths < 25 days or > 45 days, or have amenorrhea, eumenorrhea, or polymenorrhea.
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 |
|---|---|---|
| Almond snackThe almond intervention will be roasted, unsalted almonds provided at 56 g/day for 28 days. Almonds provide approximately 350 kcals/day. | Other | Almond snack |
| Cereal-based snackThe cereal-based intervention will be a prepared mix of cereal, pretzels, and bread sticks prepared at the WHNRC. It will be provided at the level of 350 kcals per day for 28 days. | Other | Cereal-based snack |
Primary outcome
Baseline level and change in cholecystokinin
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Cholecystokinin (CCK) measured in blood using an antibody based assay
Baseline level and change in peptide-YY
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Peptide-YY (PYY) measured in blood using an antibody based assay
Baseline level and change in glucose-like peptide 1
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Glucose-like peptide 1 (GLP-1) measured in blood using an antibody based assay
Baseline level and change in gastric inhibitory peptide
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Gastric inhibitory peptide (GIP) measured in blood using an antibody based assay
Baseline level and change in insulin
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Insulin measured in blood using an antibody based assay
Baseline level and change in glucose
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Glucose measured by standard chemistry in blood
Baseline level and change in oleoylethanolamide
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Oleoylethanolamide measured by mass spectrometry in blood
Baseline level and change in ghrelin
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Ghrelin measured in blood using an antibody based assay
Baseline level and change in leptin
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Leptin measured in blood using an antibody based assay
Baseline level and change in orexin
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Orexin measured in blood using an antibody based assay
Baseline level and change in endocannabinoid profiles
Time frame: Baseline, 60 minutes before lunch meal, and 10, 30, and 150 minutes after a lunch meal
Endocannabinoid profiles measured by mass spectrometry in blood
Baseline level and change in hunger
Time frame: Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
Self-reported feelings of hunger measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Baseline level and change in satiety
Time frame: Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
Self-reported feelings of fullness measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Change in food intake at a dinner meal
Time frame: Week 1 and 4
Calories consumed at a dinner meal following the satiety protocol
22 secondary outcomes
Body composition reference measurement
Time frame: Week 1
Change in body weight
Time frame: Weeks 0, 1, 2, 3, and 4
Change in body fat
Time frame: Weeks 0, 1, 2, 3, and 4
Change in lean body mass
Time frame: Weeks 0, 1, 2, 3, and 4
Change in total body water
Time frame: Weeks 0, 1, 2, 3, and 4
Change in waist circumference
Time frame: Week 0 and 4
Change in hip circumference
Time frame: Week 0 and 4
Change in Food Choice
Time frame: Baseline and following a lunch meal at Weeks 0 and 4
Change in food craving
Time frame: Week 0 and 4
Change in self-reported satiety
Time frame: Week 0 and 4
Power of food questionnaire
Time frame: Week 0
Food addiction questionnaire
Time frame: Week 0
Eating behavior
Time frame: Week 0
Three factor eating inventory
Time frame: Week 0
Premenstrual Syndrome
Time frame: Week 0
General health and well-being
Time frame: Week 0
Usual physical activity
Time frame: Week 0
Change in metabolic rate
Time frame: Baseline and 1 hour before lunch meal, 1 hour after lunch meal, and 1 hour after mid-afternoon snack
Change in dietary intake
Time frame: Ten dietary recalls collected at home during weeks 1-4
Genetic risk of obesity
Time frame: Week 1
Change in liver fat
Time frame: Week 0 and 4
Change in liver stiffness
Time frame: Week 0 and 4
Results and safety
The study was stopped early (reason given: After delay due to pandemic, sponsor declined to continue funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Eating Behavior
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II
Avoidant/Restrictive Food Intake Disorder (ARFID)
Enrolling by invitationObservational study
NutFinForce - Lifestyle Performance Medicine Intervention on Defense Performance in Finland
No Condition
RecruitingObservational study
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Pregnancy Related
Not yet recruitingPhase 2
An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa
Anorexia Nervosa
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond snack and Cereal-based snack in people with Eating Behavior and Overweight, run by USDA, Western Human 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 Oct 2024. 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 was stopped early (reason given: After delay due to pandemic, sponsor declined to continue funding.). Results are not available in the source record.
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?
Baseline level and change in cholecystokinin (time frame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2024.