Overweight and ObesityNCT04484974
Effects of Pecan Nut Snacks v Equicaloric Snacks on Appetite, Food Intake, Metabolism, Hormones and Biomarkers
A study testing Pecan snack and Tortilla chip snack in people with Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a within-subjects crossover study that examines subjective appetite, food intake, hormone and metabolic responses to consumption of mid morning snacks of pecan nuts as compared to an iso-caloric amount of tortilla chips. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Pecan snack and Tortilla chip snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2020to 19 Sep 2023
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 35 adult men and women
- all ethnic groups
- ages 20-50,
- BMI 27-35,
- habitually eat breakfast,
- willing to eat the test snacks and other foods offered,
- weight stable for the last 6 months
- willing to consent and adhere to the test procedures and schedule
Who cannot join
- nut allergies,
- uncontrolled thyroid disorders,
- diabetes mellitus,
- eating disorders,
- pregnant, or planning to become pregnant during the study,
- lactating,
Show all 12Show fewer
- uncontrolled hypertension,
- active dieting
- intensive physical activity training regimen (>300 min/wk exercise),
- medical history or current medication that may affect study outcomes per study PI discretion
- consuming pecans on a regular basis
- unable to lie still with a clear hood over their head for the measurement of energy expenditure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, 80045
About this study
Official title: A Randomized, Two Condition, Crossover Trial Assessing Appetite, Energy Metabolism, Blood Biomarker and ad Libitum Food Intake Responses to a Mid-morning Pecan Snack vs. an Equicaloric High Carbohydrate Savory Snack in Healthy Volunteers With Overweight/Obesity
This is a within-subjects crossover study that examines subjective appetite, food intake, hormone and metabolic responses to consumption of mid morning snacks of pecan nuts as compared to an iso-caloric amount of tortilla chips. Pecans are high in fat and calories and low in carbohydrate by weight, while tortilla chips are mostly carbohydrate and essentially devoid of fat. These two very different nutrient profiles should elicit different metabolic and biomarker responses. The study aims to determine whether these treatments also elicit different subjective appetite and food intake responses. Participants will be healthy volunteers with overweight and obesity, a population that may be seeking healthy snacking options that are satisfying and satiating.
Read the detailed description
This is a randomized, two condition, crossover study in healthy individuals with overweight and obesity examining the effect of a mid-morning snack of pecans vs. a low fat savory snack on appetite, energy expenditure, blood biomarkers of appetite and metabolism and ad libitum food intake at lunch. Twenty-four participants will be enrolled and studied on two test days with at least one week washout in between. On test days, participants will have baseline measures of appetite (by Visual Analogue Scale (VAS)), blood hormones and substrates, and energy expenditure and fuel oxidation (Resting Metabolic Rate (RMR), by indirect calorimetry) taken just prior to consuming a standardized 300 kcal breakfast. VAS measures will be taken at 20, 30, 60, 90 and 120 min following the meal and RMR will be measured for 20 min after eating. A mid-morning snack of either 250 kcal of pecans or lightly salted tortilla chips will be consumed and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min following the snack and RMR will be measured for 20 min after eating. Participants will be given an ad libitum lunch meal and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min following the lunch and RMR will be measured for 20 min after eating. Blood will be analyzed for glucose, insulin, free fatty acids, triglycerides, ghrelin, leptin, PYY, and GLP-1. Two hypotheses will be examined: 1. pecans will provoke greater feelings of fullness and reduced hunger after the snack and lunch meal consumption (on either a calorie per calorie or volume basis) as compared to the tortilla chip snack, and 2. the pecan snack will provoke greater responses of satiety hormones compared to tortilla chips. Post-snack and lunch energy expenditure and fat oxidation will also be compared between treatments as an exploratory aim.
- Conditions
- Overweight and Obesity
- Being tested
- Pecan snack, Tortilla chip snack
- Keywords
- Pecans, appetite, hormones, food intake
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan snackOther
Under this condition, each participant will consume a mid morning snack of pecans followed by an ad libitum lunch.
Tortilla chip snackOther
Under this condition, each participant will consume a mid morning snack consisting of an iso-caloric (equal to the pecan snack) snack of tortilla chips followed by an ad libitum lunch.
| Study group | Role | What they receive |
|---|---|---|
| Pecan snack condition | Experimental | In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted roasted pecan nuts will be administered. Receives: Other: Pecan snack |
| Tortilla chip snack condition | Active comparator | In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted pretzels will be administered. Receives: Other: Tortilla chip snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment
Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: "How hungry are you right now?" and anchored on the left by "not at all hungry" and by "extremely hungry" on the right; Fullness will be queried by "How full do you feel right now?" anchored by "not at all..." and "extremely..."; Desire to eat will be queried by, "How strong is your desire to eat right now?" anchored by anchored by "not at all..." and "extreme...; and prospective consumption will be queried by, "how much food do you think you can you eat right now" with anchors of "not (much) at all" to "extremely/an extreme amount".
Measured: Baseline (prior to mid-morning snack consumption) to 120 minutes after snack consumption at 20, 30, 60, 90 and 120 minutes following consumption.
Change from baseline (prior to lunch) to 120 minutes in subjective appetite response to lunch meal using visual analog assessment
Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: "How hungry are you right now?" and anchored on the left by "not at all hungry" and by "extremely hungry" on the right; Fullness will be queried by "How full do you feel right now?" anchored by "not at all..." and "extremely..."; Desire to eat will be queried by, "How strong is your desire to eat right now?" anchored by anchored by "not at all..." and "extreme...; and prospective consumption will be queried by, "how much food do you think you can you eat right now" with anchors of "not (much) at all" to "extremely/an extreme amount".
Measured: Prior to lunch consumption and at 20, 30, 60, 90 and 120 minutes following consumption.
Energy intake response to pecan or pretzel snack using weighed food intake measures
Energy intake at ad libitum lunch meal consisting of a variety of different foods offering approximately 1400 of kilocalories of energy having an overall composition of approximately 15% protein, 55% carbohydrate and 30% fat. Twelve ounces of water will be provided as the beverage. Energy intake will be calculated from the weight of each food consumed and the published nutrient composition of the foods. Linear mixed effects model will be used to test the difference in energy intake between two experimental conditions.
Measured: 30 minutes allowed for completion of the lunch meal
Change from baseline (prior to snack consumption) to 120 minutes in serum glucose following pecan or pretzel snack consumption.
Serum glucose by enzymatic method.
Measured: Baseline (prior to snack) to 120 minutes at intervals of 20, 30, 60, 90 and 120 minutes.
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucose following lunch consumption.
Serum glucose by enzymatic method.
Measured: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum insulin following pecan or pretzel snack consumption.
Serum insulin by radio-immunoassay.
Measured: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum insulin following lunch consumption.
Serum insulin by radio-immunoassay.
Measured: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum triglycerides following pecan or pretzel snack consumption.
Serum triglycerides by enzymatic assay.
Measured: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum triglycerides following lunch consumption.
Serum triglycerides by enzymatic assay.
Measured: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum free fatty acids following snack consumption.
Serum free fatty acids by enzymatic assay.
Measured: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum free fatty acids following lunch consumption.
Serum free fatty acids by enzymatic assay.
Measured: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum ghrelin following snack consumption.
Serum ghrelin by radio-immunoassay
Measured: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum ghrelin following lunch consumption.
Serum ghrelin by radio-immunoassay
Measured: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum peptide YY following snack consumption.
Serum peptide YY (PYY) by radio-immunoassay
Measured: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum peptide YY following lunch consumption.
Serum peptide YY (PYY) by radio-immunoassay
Measured: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change from baseline (prior to snack consumption) to 120 minutes in serum glucagon like peptide-1 following snack consumption.
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Measured: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucagon like peptide-1 following lunch consumption.
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Measured: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Change in serum leptin from baseline to 120 minutes following snack consumption
Serum leptin by immunoassay.
Measured: Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.
Secondary outcomes (2)
Change from baseline in energy expenditure post snack
Post snack resting energy expenditure will be measured using hood indirect calorimetry. Energy expenditure will be measured using standard indirect calorimetry with the ventilated hood technique (Parvo Medics Truemax 2400, Salt Lake City, UT).
Measured: Resting energy expenditure will be measured for 20 minutes after snack consumption.
Change from baseline in energy expenditure post lunch
Post lunch resting energy expenditure will be measured using hood indirect calorimetry. Energy expenditure will be measured using standard indirect calorimetry with the ventilated hood technique (Parvo Medics Truemax 2400, Salt Lake City, UT).
Measured: Resting energy expenditure will be measured for 20 minutes after lunch consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start23 Jun 2020
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Randomized, two period crossover with two treatment conditions
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Pecan Council
- Responsible party
- Sponsor
- Investigators
- John C Peters, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484974
- Sponsor's protocol ID
- 20-0048
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2020
- Last updated
- 5 Jul 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two Condition, Crossover Trial Assessing Appetite, Energy Metabolism, Blood Biomarker and ad Libitum Food Intake Responses to a Mid-morning Pecan Snack vs. an Equicaloric High Carbohydrate Savory Snack in Healthy Volunteers With Overweight/Obesity
- ClinicalTrials.gov ID
- NCT04484974
- Acronym / sponsor ID
- 20-0048
- Conditions
- Overweight and Obesity
- Keywords
- Pecans, appetite, hormones, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Pecan Council
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 24 Jul 2020 (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 is a within-subjects crossover study that examines subjective appetite, food intake, hormone and metabolic responses to consumption of mid morning snacks of pecan nuts as compared to an iso-caloric amount of tortilla chips. Pecans are high in fat and calories and low in carbohydrate by weight, while tortilla chips are mostly carbohydrate and essentially devoid of fat. These two very different nutrient profiles should elicit different metabolic and biomarker responses. The study aims to determine whether these treatments also elicit different subjective appetite and food intake responses. Participants will be healthy volunteers with overweight and obesity, a population that may be seeking healthy snacking options that are satisfying and satiating.
Detailed description
This is a randomized, two condition, crossover study in healthy individuals with overweight and obesity examining the effect of a mid-morning snack of pecans vs. a low fat savory snack on appetite, energy expenditure, blood biomarkers of appetite and metabolism and ad libitum food intake at lunch. Twenty-four participants will be enrolled and studied on two test days with at least one week washout in between. On test days, participants will have baseline measures of appetite (by Visual Analogue Scale (VAS)), blood hormones and substrates, and energy expenditure and fuel oxidation (Resting Metabolic Rate (RMR), by indirect calorimetry) taken just prior to consuming a standardized 300 kcal breakfast. VAS measures will be taken at 20, 30, 60, 90 and 120 min following the meal and RMR will be measured for 20 min after eating. A mid-morning snack of either 250 kcal of pecans or lightly salted tortilla chips will be consumed and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min following the snack and RMR will be measured for 20 min after eating. Participants will be given an ad libitum lunch meal and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min following the lunch and RMR will be measured for 20 min after eating. Blood will be analyzed for glucose, insulin, free fatty acids, triglycerides, ghrelin, leptin, PYY, and GLP-1. Two hypotheses will be examined: 1. pecans will provoke greater feelings of fullness and reduced hunger after the snack and lunch meal consumption (on either a calorie per calorie or volume basis) as compared to the tortilla chip snack, and 2. the pecan snack will provoke greater responses of satiety hormones compared to tortilla chips. Post-snack and lunch energy expenditure and fat oxidation will also be compared between treatments as an exploratory aim.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, two period crossover with two treatment conditions
| Arm | Type | Receives |
|---|---|---|
| Pecan snack condition | Experimental | Other: Pecan snackIn this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted roasted pecan nuts will be administered. |
| Tortilla chip snack condition | Active comparator | Other: Tortilla chip snackIn this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted pretzels will be administered. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 35 adult men and women
- all ethnic groups
- ages 20-50,
- BMI 27-35,
- habitually eat breakfast,
Key exclusion criteria (12 listed)
- nut allergies,
- uncontrolled thyroid disorders,
- diabetes mellitus,
- eating disorders,
- pregnant, or planning to become pregnant during the study,
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 |
|---|---|---|
| Pecan snackUnder this condition, each participant will consume a mid morning snack of pecans followed by an ad libitum lunch. | Other | Pecan snack condition |
| Tortilla chip snackUnder this condition, each participant will consume a mid morning snack consisting of an iso-caloric (equal to the pecan snack) snack of tortilla chips followed by an ad libitum lunch. | Other | Tortilla chip snack condition |
Primary outcome
Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment
Time frame: Baseline (prior to mid-morning snack consumption) to 120 minutes after snack consumption at 20, 30, 60, 90 and 120 minutes following consumption.
Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: "How hungry are you right now?" and anchored on the left by "not at all hungry" and by "extremely hungry" on the right; Fullness will be queried by "How full do you feel right now?" anchored by "not at all..." and "extremely..."; Desire to eat will be queried by, "How strong is your desire to eat right now?" anchored by anchored by "not at all..." and "extreme...; and prospective consumption will be queried by, "how much food do you think you can you eat right now" with anchors of "not (much) at all" to "extremely/an extreme amount".
Change from baseline (prior to lunch) to 120 minutes in subjective appetite response to lunch meal using visual analog assessment
Time frame: Prior to lunch consumption and at 20, 30, 60, 90 and 120 minutes following consumption.
Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: "How hungry are you right now?" and anchored on the left by "not at all hungry" and by "extremely hungry" on the right; Fullness will be queried by "How full do you feel right now?" anchored by "not at all..." and "extremely..."; Desire to eat will be queried by, "How strong is your desire to eat right now?" anchored by anchored by "not at all..." and "extreme...; and prospective consumption will be queried by, "how much food do you think you can you eat right now" with anchors of "not (much) at all" to "extremely/an extreme amount".
Energy intake response to pecan or pretzel snack using weighed food intake measures
Time frame: 30 minutes allowed for completion of the lunch meal
Energy intake at ad libitum lunch meal consisting of a variety of different foods offering approximately 1400 of kilocalories of energy having an overall composition of approximately 15% protein, 55% carbohydrate and 30% fat. Twelve ounces of water will be provided as the beverage. Energy intake will be calculated from the weight of each food consumed and the published nutrient composition of the foods. Linear mixed effects model will be used to test the difference in energy intake between two experimental conditions.
Change from baseline (prior to snack consumption) to 120 minutes in serum glucose following pecan or pretzel snack consumption.
Time frame: Baseline (prior to snack) to 120 minutes at intervals of 20, 30, 60, 90 and 120 minutes.
Serum glucose by enzymatic method.
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucose following lunch consumption.
Time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum glucose by enzymatic method.
Change from baseline (prior to snack consumption) to 120 minutes in serum insulin following pecan or pretzel snack consumption.
Time frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum insulin by radio-immunoassay.
Change from baseline (prior to lunch consumption) to 120 minutes in serum insulin following lunch consumption.
Time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum insulin by radio-immunoassay.
Change from baseline (prior to snack consumption) to 120 minutes in serum triglycerides following pecan or pretzel snack consumption.
Time frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum triglycerides by enzymatic assay.
Change from baseline (prior to lunch consumption) to 120 minutes in serum triglycerides following lunch consumption.
Time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum triglycerides by enzymatic assay.
Change from baseline (prior to snack consumption) to 120 minutes in serum free fatty acids following snack consumption.
Time frame: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum free fatty acids by enzymatic assay.
Change from baseline (prior to lunch consumption) to 120 minutes in serum free fatty acids following lunch consumption.
Time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum free fatty acids by enzymatic assay.
Change from baseline (prior to snack consumption) to 120 minutes in serum ghrelin following snack consumption.
Time frame: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum ghrelin by radio-immunoassay
Change from baseline (prior to lunch consumption) to 120 minutes in serum ghrelin following lunch consumption.
Time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum ghrelin by radio-immunoassay
Change from baseline (prior to snack consumption) to 120 minutes in serum peptide YY following snack consumption.
Time frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum peptide YY (PYY) by radio-immunoassay
Change from baseline (prior to lunch consumption) to 120 minutes in serum peptide YY following lunch consumption.
Time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum peptide YY (PYY) by radio-immunoassay
Change from baseline (prior to snack consumption) to 120 minutes in serum glucagon like peptide-1 following snack consumption.
Time frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Change from baseline (prior to lunch consumption) to 120 minutes in serum glucagon like peptide-1 following lunch consumption.
Time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
Change in serum leptin from baseline to 120 minutes following snack consumption
Time frame: Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.
Serum leptin by immunoassay.
2 secondary outcomes
Change from baseline in energy expenditure post snack
Time frame: Resting energy expenditure will be measured for 20 minutes after snack consumption.
Change from baseline in energy expenditure post lunch
Time frame: Resting energy expenditure will be measured for 20 minutes after lunch consumption.
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 5 Jul 2024.
- Individual participant dataSharing planned: No
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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.
John C Peters, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecan snack and Tortilla chip snack in people with Overweight and Obesity, run by University of Colorado, Denver 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 8 inclusion and 12 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 5 Jul 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 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?
Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment (time frame: Baseline (prior to mid-morning snack consumption) to 120 minutes after snack consumption at 20, 30, 60, 90 and 120 minutes following consumption.). The study lists 18 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 5 Jul 2024.