Healthy IndividualNCT03227874
Effects of Dried Apple on Metabolic Responses
A study testing Dried apple and Muffin in people with Healthy Individual, run by San Diego State University at 1 site in United States.
Trial summary
Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased cardiovascular disease risk. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individual
- What is being tested?
- Dried apple and Muffin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2015to 29 Jan 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-45 years
- body mass index (BMI; in kg/m2): 18-25.
Who cannot join
- past head injuries,
- cigarette smoking,
- pregnancy,
- allergies to test foods,
- chronic use of medications known to affect metabolism,
- presence of any disorder or medications affecting metabolism (e.g., diabetes, hyperthyroidism, phenylketonuria, obesity, glycogen storage diseases, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State Univeristy
San Diego, California, 92182
About this study
Official title: Acute Effects of Dried Apple Consumption on Metabolic Responses in Healthy Individuals
Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased cardiovascular disease risk. Metabolic syndrome is highly prevalent with the growing trend of obesity that characterizes the US, with 34% of adults 20 years of age and older meeting the criteria. The number of people with diabetes is expected to increase dramatically over the next decades, coinciding with rising obesity rates in many countries. Recent studies have highlighted the beneficial effects of apple and apple products in reducing the risk of chronic disease due to their rich content of fiber, nutrients and various phytochemicals. The primary objective of the proposed research is to determine the acute effect of consumption of 240 kcal servings of dried apples versus a lowfat/high fiber muffin on blood glucose, serum insulin, and fullness (satiety). The secondary objective of the proposed research is to determine the acute effect of consumption of dried apple versus a low-fat muffin on various cognitive domains. As with any organ, the brain requires nutrients to build and maintain its structure and function, in order to perform in a harmonious manner and avoid damage from aging. Epidemiological, clinical and basic research studies suggest protective effects of several classes of nutrients against cognitive decline and risk of dementia. Twenty five male and female participants between the ages of 20-45 years with a body mass index (BMI) between 18 and 25 will be recruited to participate in the study at San Diego State University. Each participant will consume both test foods, the dried apple and muffin, on two separate visits to the lab at least a week apart. The participants will come to each lab visit after a 10 hour overnight fast. After arriving at the laboratory, the participant's will complete a cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive tests on a computer. Next After arriving at the lab, blood samples will be collected from warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain an ample blood collection for analysis of baseline plasma concentrations of glucose and insulin. The participants will then be given 5 minutes to consume the test food. Subsequent finger-prick blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes. The participants will also rate their feelings of fullness on a visual scale prior to consumption of the test food and every 15 minutes for two hours after consumption. After the completion of the finger-prick blood samples and satiety questionnaires the participants will complete a cognitive post-test which will be a different version of the cognitive pre-test battery. Concentrations of glucose will be assessed by a handheld glucose monitor as well as an enzymatic kit. Insulin will be assessed by ELISA or radioimmunoassay. Differences in all dependent variables between the trials will be determined using a repeated measures ANOVA and followed post-hoc when appropriate using paired T-tests to take advantage of the higher statistical power provided by paired comparisons. Data will be reported as means +/- SD. Significance will be selected at an alpha level of P < 0.05. These data may be useful as finding a snack source that produces a lower glycemic response and a greater satiating effect could be valuable in dietary counseling for blood glucose maintenance. For the cognitive portion of this research, these data may be useful because there is considerable room for improvement and for expanding evidence-based knowledge on the link between nutrition and cognition.
Read the detailed description
Before each trial, subjects will fast for 10 hours. The 10-hour period of fasting is enough for development of the satiety index methodology. Subjects will be asked to refrain from caffeine and alcohol consumption, as well as strenuous exercise for the 32 hours prior to each blood collection. For both trials, participants will report to the lab at the same time each morning following the overnight fast. The subjects will report to the lab twice at least a week apart; once for the dried apple (240 kcal) trial and once the muffin (240 kcal) trial. After arriving at the lab, the participants will complete a cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive tests on a computer. The cognitive pre- and post-tests will evaluate the following; verbal memory, visual memory, psychomotor speed, executive function, cognitive flexibility and reaction time. The participants will use their dominant hand to take the computerized test (except when indicated during the testing to use a specific hand during the "Finger Tapping Test") and will be asked to place their hand at the center of the space bar and keep their hand there during the cognitive testing. Participant's compliance and behaviors will be observed and noted by a research assistant. Next blood samples will be collected from warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain an ample blood collection for analysis of baseline plasma concentrations of glucose and insulin. Following baseline blood collection, subjects will rank their level of satiety and then consume the dried apple in their first visit to the lab and the muffin in their second visit to the lab. Subsequent blood samples and satiety ratings will be collected 15, 30, 45, 60, 90 and 120 minutes following the beginning of food consumption. Wash-out periods of at least a week between trials will allow for unbiased satiety index reporting by subjects. The satiety index of dried apple and muffin will be determined. Subjects will rate satiety on a 100 mm 7-point visual scale. Subjects will rank their level of satiety at any point along the scale. Participants will complete rankings on the scale prior to test food consumption and every 15 minutes after test food consumption. Participants will not have access to previously marked scales throughout the testing period. The developers of the satiety index have demonstrated that this scale provides greater retest reproducibility than a simple visual analog scale. Immediately after test food consumption, time required for food consumption will be recorded. Participants will answer the following questions using 100 mm visual analog scales (scale anchors indicated in parentheses). 1. How much did you like the meal? (0=Dislike extremely, 100=Like extremely) 2. How difficult was the food to eat? (0=Not at all difficult, 100=Extremely difficult) 3. Was the serving size sufficient? (0=Not at all enough, 100=Far too much) 4. How much more of this food would you like to eat? (0=Nothing at all, 100 A large amount) 5. Do you feel like eating something else? (0=Nothing at all, 100=A whole meal) 6. How much more food would you need to eat to completely satisfy your hunger? (0=Nothing at all, 100=A large amount) 7. Do you feel like eating something sweet (0=Not at all sweet, 100=Very sweet) 8. Do you feel like eating something salty (0=Not at all salty, 100=Very salty) 9. Do you feel like eating something savory (0=Not at all savory, 100=Very savory). Subjects will listen to a standardized playlist of music in between tests. Finally after the blood samples a satiety ratings are completed the participants will have a 10 minute break and then complete the cognitive post-test (Concussion Vital Signs Test Battery). The post-test will be a different version of the pre-test but the eight tests will remain in the same order for consistency. Prior to initiation of the study, an ample supply of dried apple and muffin will be obtained for the entire study. Collected blood will be centrifuged at 4°C to obtain plasma. Plasma will be stored in cryogenic vials at -70°C for batch analysis. Plasma glucose and insulin will be assessed at each time point. Glucose will be analyzed colorimetrically with kits from Stanbio Laboratory (Boerne, TX). Insulin will be determined using a radioimmunoassay from Diagnostics Products Corporation (Los Angeles, CA). The area under the glycemic response curve for the dried apple and muffin will be expressed relative to the mean response to glucose. Results will be reported as mean ± standard error of mean. Satiety index will be calculated as previously described as a measure of area under the curve for dried apple relative to muffin. Statistical analyses will be conducted using the Statistics Program for Social Sciences (SPSS) computer software package. Differences in glycemic index, satiety index, answers to visual analog scales, cognitive test scores and areas under the curve for biochemical parameters between different food trials will be determined using paired T-tests. Differences in other variables will be assessed with repeated measures ANOVAs and post-hoc paired T-tests as appropriate to take advantage of the higher statistical power provided by paired comparisons. Significance will be selected at an alpha level of P<0.05.
- Conditions
- Healthy Individual
- Being tested
- Dried apple, Muffin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried appleDietary supplement
diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water.
MuffinDietary supplement
two muffins with 55 g carbohydrate, was consumed by the participants with 220 ml of water.
| Study group | Role | What they receive |
|---|---|---|
| Dried apple | Experimental | diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water. Receives: Dietary Supplement: Dried apple; Dietary Supplement: Muffin |
| Muffin | Experimental | two muffins, each with 55 g carbohydrate, was consumed by the participants with 220 ml of water. Receives: Dietary Supplement: Dried apple; Dietary Supplement: Muffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose response
blood glucose using reagent
Measured: Changes from 0 to 120 minutes after consumption of test food
serum insulin response
serum insulin using ELISA
Measured: Changes from 0 to 120 minutes after consumption of test food
Secondary outcomes (2)
various cognitive domains
concussion vital signs test battery
Measured: baseline and two hour after test food consumption
Satiety
Satiety using 100 mm 7 point visual scale
Measured: Changes from 0 to 120 minutes after consumption of test food
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start23 Sep 2015
- Primary completion6 Nov 2015
- Study completion29 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shirin Hooshmand, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227874
- Sponsor's protocol ID
- 2040097
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 24 Jul 2017
- 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 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Dried Apple Consumption on Metabolic Responses in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03227874
- Acronym / sponsor ID
- 2040097
- Conditions
- Healthy Individual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 23 Sep 2015 (actual)
- Primary completion
- 6 Nov 2015 (actual)
- Study completion
- 29 Jan 2016 (actual)
- First posted
- 24 Jul 2017 (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.
Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased cardiovascular disease risk. Metabolic syndrome is highly prevalent with the growing trend of obesity that characterizes the US, with 34% of adults 20 years of age and older meeting the criteria. The number of people with diabetes is expected to increase dramatically over the next decades, coinciding with rising obesity rates in many countries. Recent studies have highlighted the beneficial effects of apple and apple products in reducing the risk of chronic disease due to their rich content of fiber, nutrients and various phytochemicals. The primary objective of the proposed research is to determine the acute effect of consumption of 240 kcal servings of dried apples versus a lowfat/high fiber muffin on blood glucose, serum insulin, and fullness (satiety). The secondary objective of the proposed research is to determine the acute effect of consumption of dried apple versus a low-fat muffin on various cognitive domains. As with any organ, the brain requires nutrients to build and maintain its structure and function, in order to perform in a harmonious manner and avoid damage from aging. Epidemiological, clinical and basic research studies suggest protective effects of several classes of nutrients against cognitive decline and risk of dementia. Twenty five male and female participants between the ages of 20-45 years with a body mass index (BMI) between 18 and 25 will be recruited to participate in the study at San Diego State University. Each participant will consume both test foods, the dried apple and muffin, on two separate visits to the lab at least a week apart. The participants will come to each lab visit after a 10 hour overnight fast. After arriving at the laboratory, the participant's will complete a cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive tests on a computer. Next After arriving at the lab, blood samples will be collected from warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain an ample blood collection for analysis of baseline plasma concentrations of glucose and insulin. The participants will then be given 5 minutes to consume the test food. Subsequent finger-prick blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes. The participants will also rate their feelings of fullness on a visual scale prior to consumption of the test food and every 15 minutes for two hours after consumption. After the completion of the finger-prick blood samples and satiety questionnaires the participants will complete a cognitive post-test which will be a different version of the cognitive pre-test battery. Concentrations of glucose will be assessed by a handheld glucose monitor as well as an enzymatic kit. Insulin will be assessed by ELISA or radioimmunoassay. Differences in all dependent variables between the trials will be determined using a repeated measures ANOVA and followed post-hoc when appropriate using paired T-tests to take advantage of the higher statistical power provided by paired comparisons. Data will be reported as means +/- SD. Significance will be selected at an alpha level of P < 0.05. These data may be useful as finding a snack source that produces a lower glycemic response and a greater satiating effect could be valuable in dietary counseling for blood glucose maintenance. For the cognitive portion of this research, these data may be useful because there is considerable room for improvement and for expanding evidence-based knowledge on the link between nutrition and cognition.
Detailed description
Before each trial, subjects will fast for 10 hours. The 10-hour period of fasting is enough for development of the satiety index methodology. Subjects will be asked to refrain from caffeine and alcohol consumption, as well as strenuous exercise for the 32 hours prior to each blood collection. For both trials, participants will report to the lab at the same time each morning following the overnight fast. The subjects will report to the lab twice at least a week apart; once for the dried apple (240 kcal) trial and once the muffin (240 kcal) trial. After arriving at the lab, the participants will complete a cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive tests on a computer. The cognitive pre- and post-tests will evaluate the following; verbal memory, visual memory, psychomotor speed, executive function, cognitive flexibility and reaction time. The participants will use their dominant hand to take the computerized test (except when indicated during the testing to use a specific hand during the "Finger Tapping Test") and will be asked to place their hand at the center of the space bar and keep their hand there during the cognitive testing. Participant's compliance and behaviors will be observed and noted by a research assistant. Next blood samples will be collected from warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain an ample blood collection for analysis of baseline plasma concentrations of glucose and insulin. Following baseline blood collection, subjects will rank their level of satiety and then consume the dried apple in their first visit to the lab and the muffin in their second visit to the lab. Subsequent blood samples and satiety ratings will be collected 15, 30, 45, 60, 90 and 120 minutes following the beginning of food consumption. Wash-out periods of at least a week between trials will allow for unbiased satiety index reporting by subjects. The satiety index of dried apple and muffin will be determined. Subjects will rate satiety on a 100 mm 7-point visual scale. Subjects will rank their level of satiety at any point along the scale. Participants will complete rankings on the scale prior to test food consumption and every 15 minutes after test food consumption. Participants will not have access to previously marked scales throughout the testing period. The developers of the satiety index have demonstrated that this scale provides greater retest reproducibility than a simple visual analog scale. Immediately after test food consumption, time required for food consumption will be recorded. Participants will answer the following questions using 100 mm visual analog scales (scale anchors indicated in parentheses). 1. How much did you like the meal? (0=Dislike extremely, 100=Like extremely) 2. How difficult was the food to eat? (0=Not at all difficult, 100=Extremely difficult) 3. Was the serving size sufficient? (0=Not at all enough, 100=Far too much) 4. How much more of this food would you like to eat? (0=Nothing at all, 100 A large amount) 5. Do you feel like eating something else? (0=Nothing at all, 100=A whole meal) 6. How much more food would you need to eat to completely satisfy your hunger? (0=Nothing at all, 100=A large amount) 7. Do you feel like eating something sweet (0=Not at all sweet, 100=Very sweet) 8. Do you feel like eating something salty (0=Not at all salty, 100=Very salty) 9. Do you feel like eating something savory (0=Not at all savory, 100=Very savory). Subjects will listen to a standardized playlist of music in between tests. Finally after the blood samples a satiety ratings are completed the participants will have a 10 minute break and then complete the cognitive post-test (Concussion Vital Signs Test Battery). The post-test will be a different version of the pre-test but the eight tests will remain in the same order for consistency. Prior to initiation of the study, an ample supply of dried apple and muffin will be obtained for the entire study. Collected blood will be centrifuged at 4°C to obtain plasma. Plasma will be stored in cryogenic vials at -70°C for batch analysis. Plasma glucose and insulin will be assessed at each time point. Glucose will be analyzed colorimetrically with kits from Stanbio Laboratory (Boerne, TX). Insulin will be determined using a radioimmunoassay from Diagnostics Products Corporation (Los Angeles, CA). The area under the glycemic response curve for the dried apple and muffin will be expressed relative to the mean response to glucose. Results will be reported as mean ± standard error of mean. Satiety index will be calculated as previously described as a measure of area under the curve for dried apple relative to muffin. Statistical analyses will be conducted using the Statistics Program for Social Sciences (SPSS) computer software package. Differences in glycemic index, satiety index, answers to visual analog scales, cognitive test scores and areas under the curve for biochemical parameters between different food trials will be determined using paired T-tests. Differences in other variables will be assessed with repeated measures ANOVAs and post-hoc paired T-tests as appropriate to take advantage of the higher statistical power provided by paired comparisons. Significance will be selected at an alpha level of P<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dried apple | Experimental | Dietary Supplement: Dried apple, Dietary Supplement: Muffindiced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water. |
| Muffin | Experimental | Dietary Supplement: Dried apple, Dietary Supplement: Muffintwo muffins, each with 55 g carbohydrate, was consumed by the participants with 220 ml of water. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 20-45 years
- body mass index (BMI; in kg/m2): 18-25.
Key exclusion criteria (6 listed)
- past head injuries,
- cigarette smoking,
- pregnancy,
- allergies to test foods,
- chronic use of medications known to affect metabolism,
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 |
|---|---|---|
| Dried applediced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water. | Dietary supplement | Dried apple, Muffin |
| Muffintwo muffins with 55 g carbohydrate, was consumed by the participants with 220 ml of water. | Dietary supplement | Dried apple, Muffin |
Primary outcome
blood glucose response
Time frame: Changes from 0 to 120 minutes after consumption of test food
blood glucose using reagent
serum insulin response
Time frame: Changes from 0 to 120 minutes after consumption of test food
serum insulin using ELISA
2 secondary outcomes
various cognitive domains
Time frame: baseline and two hour after test food consumption
Satiety
Time frame: Changes from 0 to 120 minutes after consumption of test food
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 24 Jul 2017.
- 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.
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 Dried apple and Muffin in people with Healthy Individual, run by San Diego State University 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 6 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 24 Jul 2017. 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?
blood glucose response (time frame: Changes from 0 to 120 minutes after consumption of test food). The study lists 2 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 24 Jul 2017.