ObesityNCT01115088
Effects of Stevia on Satiety and Eating Attitudes in Healthy, Overweight and Obese Adults
A study testing Aspartame, Sucrose and Stevia in people with Obesity and Type 2 Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to test the effects that three different types of sweeteners have on food intake, hunger and satiety levels, as well as insulin and glucose measures. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Aspartame, Sucrose and Stevia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and have a body mass index > 30 kg/m2 and < 39.9 kg/m2, or have a body mass index > 20 kg/m2 and < 24.9 kg/m2
- If BMI is between 30 and 39.9, waist circumference must be > 36 for women and > 40 for men.
- Age 18 to 45 years
- Nonsmokers
- Willing to consume meat products
- Women on monophasic oral contraceptives or who have physiologically controlled cycles
Who cannot join
- A history of diabetes, cardiovascular disease, or other chronic illnesses
- Presence of an eating disorder including Anorexia and/or Bulimia Nervosa
- Other health problems that might interfere with your ability to participate in the study
- Taking medications, other than monophasic birth control or monophasic (same dose every day) hormone replacement therapy and allergy medication
- Taking allergy medication for a period of time less than 6 months
- Dislike of or allergy to foods/sweeteners (Sucrose, Stevia, or Aspartame) used in test meals
Show all 9Show fewer
- Smokers
- High scores on the Dietary Restraint, Disinhibition, and Perceived Hunger scales of the Three Factor Eating Questionnaire
- Use of oral contraceptives other than monophasic (same dose every day) contraceptives
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Effects of Stevia on Satiety and Eating Attitudes in Healthy, Overweight and Obese Adults: A Pilot Study
The purpose of this study is to test the effects that three different types of sweeteners have on food intake, hunger and satiety levels, as well as insulin and glucose measures. The study of whether food or beverages containing Stevia influence food intake to a greater extent than food or beverages sweetened with Aspartame or Sucrose. Also, examining whether taste preference and taste sensitivity influence food intake.
Read the detailed description
Expected time in this study will be approximately 24 hours spread over the course of one initial screening visit and three test days during which you complete food tests at the Pennington Center.
Screening visit (Duration is 3 hours)
- You will initially be asked to fill out psychological questionnaires to assess your eating habits, food cravings, and preference for foods (i.e., tea and crackers with cream cheese) that will be provided to you in this study.
- You will also be asked to complete two taste tests during this visit. The first taste test will be sodium chloride (table salt) followed by PROP (an extremely low dose of hyperthyroid medication) sodium chloride (table salt).
- You will be required to provide a blood sample (19 mL or 1.3 tablespoons) to check glucose and insulin levels.
- If you are selected to be a participant for this study, you will receive a brief medical evaluation during which you will be weighed, your height will be measured, and your pulse and blood pressure will be taken. You will be interviewed about your medical history and potential obstacles for completing the study. If you are female, a brief interview will be conducted to determine your menstrual cycle phase. Total length of time will be approximately three hours for the screening visit.
First Food Test Day (Duration is 7- 9 hours. You'll arrive after having fasted for 12 hrs.) For females, all test meal days will be scheduled during their luteal phase. • Breakfast: During your first food test day, you will be asked to come to the Pennington Center at any time between the hours of 7:00 A.M. - 8:30 A.M. and consume a standard breakfast of Cheerios, milk, orange juice, toast, butter, and jelly. You will then be free to leave but will be asked to return 3.5 hours later. When your return, you will be sent to our inpatient unit for a blood draw, which will test your level of insulin and glucose (total of 25 mL or 1.67 tablespoons). You will then be asked to rate your appetite on a computer using a visual analog scale (VAS). After completing these VAS ratings, you will be provided with an appetizer of 5 ounces of cold tea and 6 crackers with cream cheese. Both the tea and the cream cheese will be sweetened with one of the following sweeteners: Aspartame, Sucrose, or Stevia. After consuming this appetizer, you will be asked to complete another set of VAS ratings, which again ask you about your appetite, as well as the sweetness of the appetizer. Test times will be constant for all visits. Approximately twenty minutes after consuming this appetizer, your insulin and glucose levels will again be tested and you will complete another set of VAS ratings before your lunch meal. You will be required to consume breakfast at the same time for all three visits. For example, if you come at 7:00 A.M. on your first test day, you will be required to come in at 7:00 A.M. on your next two test days.
- Lunch: After completing VAS ratings before lunch, you will be provided with a lunch consisting of sandwiches, chips, and cookies. Your lunch meal will be served approximately 4 hours after your breakfast meal. Your eating behavior may be monitored by weight of the food consumed and/or by video camera/tape. You may eat as much or as little of the lunch as you wish.
- After Lunch: After you finish your lunch meal, you will be asked to complete post meal VAS ratings. Your insulin and glucose will be measured on the three occasions after lunch: 30 minutes after lunch, one hour after lunch, and two hours after lunch for a total of 5 blood draws (total of 25 mL or 1.67 tablespoons). You will also be asked to complete VAS ratings 30 minutes after lunch, and every hour for the next four hours. You will spend the afternoon at the Pennington center to ensure that blood draws and VAS ratings occur at the appropriate time intervals. During the afternoon you will be free to read, do paperwork brought from home or work, or watch movies that will be provided to you by the Center.
- Dinner:
Four hours after the test lunch, you will be provided with another appetizer of 5 ounces of cold tea and crackers with cream cheese. Both the tea and the cream cheese will be sweetened with one of the following sweeteners: Stevia, sucrose, or Aspartame. You will complete VAS ratings before and after this appetizer, as well as before and after your dinner meal (4.5 hours after lunch), during which you will be instructed to eat as much or as little of any of the items presented as you want. Your eating behavior may be monitored by weight of the food consumed and/or by video camera/tape. After you complete VAS questions after the evening meal, you will have fulfilled the requirements of the first food test day. However, you will be asked not to consume any food or caloric beverages for three hours following your dinner meal. You will be asked to report any adverse events from this day at this visit.
Second Food Test Day (Duration is 7-9 hours. You'll arrive after having fasted for 12 hrs.) • On your second food test day, you will complete the same procedures and meal tests as you did during the first food test day. However, the type of sweetener used in your tea and crackers with cream cheese will differ from the type of sweetener you received on your first food test day. You will be asked to report any adverse events from this day, as well as previous visits, at this visit.
Third Food Test Day (Duration is 7-9 hours. You'll arrive after having fasted for 12 hrs.)
- On your third food test day, you will complete the same procedures and meal tests as you did during your two previous food test days. However, the type of sweetener used in your tea and crackers with cream cheese will differ from the type of sweetener you received on previous visits. You will also be asked to report any adverse events from this day, as well as previous visits, at this visit. We will also follow up by phone regarding adverse events following your third visit. Table 1 presents a schedule of the procedures that will take place at each of the study visits.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Aspartame, Sucrose, Stevia
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspartameDietary supplement
Also called equal sweetener
The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)
SucroseDietary supplement
The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)
SteviaDietary supplement
The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)
| Study group | Role | What they receive |
|---|---|---|
| Aspartame | Experimental | Food or beverages containing Aspartame in comparison to Stevia or Sucrose Receives: Dietary Supplement: Aspartame |
| Sucrose | Experimental | Food or beverages containing Sucrose in comparison to Aspartame or Stevia Receives: Dietary Supplement: Sucrose |
| Stevia | Experimental | Food or beverages containing Stevia in comparison to Aspartame or Sucrose Receives: Dietary Supplement: Stevia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels.
Test whether preloads of tea and crackers with cream cheese sweetened with Stevia lover postprandial insulin levels compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by measuring blood insulin and glucose levels immediately prior to the lunch preload,immediately before lunch test meal, and at thirty minutes, one hour, and two hours after the lunch test meal.
Measured: 24 hours
Secondary outcomes (2)
Hedonic ratings (appearance, aroma, flavor, texture and palatability)with Stevia sweetener compared to Sucrose or Aspartame
Test whether preloads of tea and crackers with cream cheese sweetened with Stevia have different hedonic ratings compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by examining hunger and satiety ratings after the preload.
Measured: 24 hours
Satiating effects by examining food consumption
Test whether preloads of tea and crackers with cream cheese sweetened with stevia have different satiating effects compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by examining food consumption 20 minutes and after lunch and dinner preloads, as well as total food consumption.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJan 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Cefalu, MD, Pennington Biomedical Research Center
- Investigators
- Stephen D. Anton, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115088
- Sponsor's protocol ID
- PBRC 25030
- Status last verified
- Feb 2016
- First submitted
- 29 Apr 2010
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stevia on Satiety and Eating Attitudes in Healthy, Overweight and Obese Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT01115088
- Acronym / sponsor ID
- PBRC 25030
- Conditions
- Obesity, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 May 2010 (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.
The purpose of this study is to test the effects that three different types of sweeteners have on food intake, hunger and satiety levels, as well as insulin and glucose measures. The study of whether food or beverages containing Stevia influence food intake to a greater extent than food or beverages sweetened with Aspartame or Sucrose. Also, examining whether taste preference and taste sensitivity influence food intake.
Detailed description
Expected time in this study will be approximately 24 hours spread over the course of one initial screening visit and three test days during which you complete food tests at the Pennington Center.
Screening visit (Duration is 3 hours)
- You will initially be asked to fill out psychological questionnaires to assess your eating habits, food cravings, and preference for foods (i.e., tea and crackers with cream cheese) that will be provided to you in this study.
- You will also be asked to complete two taste tests during this visit. The first taste test will be sodium chloride (table salt) followed by PROP (an extremely low dose of hyperthyroid medication) sodium chloride (table salt).
- You will be required to provide a blood sample (19 mL or 1.3 tablespoons) to check glucose and insulin levels.
- If you are selected to be a participant for this study, you will receive a brief medical evaluation during which you will be weighed, your height will be measured, and your pulse and blood pressure will be taken. You will be interviewed about your medical history and potential obstacles for completing the study. If you are female, a brief interview will be conducted to determine your menstrual cycle phase. Total length of time will be approximately three hours for the screening visit.
First Food Test Day (Duration is 7- 9 hours. You'll arrive after having fasted for 12 hrs.) For females, all test meal days will be scheduled during their luteal phase. • Breakfast: During your first food test day, you will be asked to come to the Pennington Center at any time between the hours of 7:00 A.M. - 8:30 A.M. and consume a standard breakfast of Cheerios, milk, orange juice, toast, butter, and jelly. You will then be free to leave but will be asked to return 3.5 hours later. When your return, you will be sent to our inpatient unit for a blood draw, which will test your level of insulin and glucose (total of 25 mL or 1.67 tablespoons). You will then be asked to rate your appetite on a computer using a visual analog scale (VAS). After completing these VAS ratings, you will be provided with an appetizer of 5 ounces of cold tea and 6 crackers with cream cheese. Both the tea and the cream cheese will be sweetened with one of the following sweeteners: Aspartame, Sucrose, or Stevia. After consuming this appetizer, you will be asked to complete another set of VAS ratings, which again ask you about your appetite, as well as the sweetness of the appetizer. Test times will be constant for all visits. Approximately twenty minutes after consuming this appetizer, your insulin and glucose levels will again be tested and you will complete another set of VAS ratings before your lunch meal. You will be required to consume breakfast at the same time for all three visits. For example, if you come at 7:00 A.M. on your first test day, you will be required to come in at 7:00 A.M. on your next two test days.
- Lunch: After completing VAS ratings before lunch, you will be provided with a lunch consisting of sandwiches, chips, and cookies. Your lunch meal will be served approximately 4 hours after your breakfast meal. Your eating behavior may be monitored by weight of the food consumed and/or by video camera/tape. You may eat as much or as little of the lunch as you wish.
- After Lunch: After you finish your lunch meal, you will be asked to complete post meal VAS ratings. Your insulin and glucose will be measured on the three occasions after lunch: 30 minutes after lunch, one hour after lunch, and two hours after lunch for a total of 5 blood draws (total of 25 mL or 1.67 tablespoons). You will also be asked to complete VAS ratings 30 minutes after lunch, and every hour for the next four hours. You will spend the afternoon at the Pennington center to ensure that blood draws and VAS ratings occur at the appropriate time intervals. During the afternoon you will be free to read, do paperwork brought from home or work, or watch movies that will be provided to you by the Center.
- Dinner:
Four hours after the test lunch, you will be provided with another appetizer of 5 ounces of cold tea and crackers with cream cheese. Both the tea and the cream cheese will be sweetened with one of the following sweeteners: Stevia, sucrose, or Aspartame. You will complete VAS ratings before and after this appetizer, as well as before and after your dinner meal (4.5 hours after lunch), during which you will be instructed to eat as much or as little of any of the items presented as you want. Your eating behavior may be monitored by weight of the food consumed and/or by video camera/tape. After you complete VAS questions after the evening meal, you will have fulfilled the requirements of the first food test day. However, you will be asked not to consume any food or caloric beverages for three hours following your dinner meal. You will be asked to report any adverse events from this day at this visit.
Second Food Test Day (Duration is 7-9 hours. You'll arrive after having fasted for 12 hrs.) • On your second food test day, you will complete the same procedures and meal tests as you did during the first food test day. However, the type of sweetener used in your tea and crackers with cream cheese will differ from the type of sweetener you received on your first food test day. You will be asked to report any adverse events from this day, as well as previous visits, at this visit.
Third Food Test Day (Duration is 7-9 hours. You'll arrive after having fasted for 12 hrs.)
- On your third food test day, you will complete the same procedures and meal tests as you did during your two previous food test days. However, the type of sweetener used in your tea and crackers with cream cheese will differ from the type of sweetener you received on previous visits. You will also be asked to report any adverse events from this day, as well as previous visits, at this visit. We will also follow up by phone regarding adverse events following your third visit. Table 1 presents a schedule of the procedures that will take place at each of the study visits.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspartame | Experimental | Dietary Supplement: AspartameFood or beverages containing Aspartame in comparison to Stevia or Sucrose |
| Sucrose | Experimental | Dietary Supplement: SucroseFood or beverages containing Sucrose in comparison to Aspartame or Stevia |
| Stevia | Experimental | Dietary Supplement: SteviaFood or beverages containing Stevia in comparison to Aspartame or Sucrose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy and have a body mass index > 30 kg/m2 and < 39.9 kg/m2, or have a body mass index > 20 kg/m2 and < 24.9 kg/m2
- If BMI is between 30 and 39.9, waist circumference must be > 36 for women and > 40 for men.
- Age 18 to 45 years
- Nonsmokers
- Willing to consume meat products
Key exclusion criteria (9 listed)
- A history of diabetes, cardiovascular disease, or other chronic illnesses
- Presence of an eating disorder including Anorexia and/or Bulimia Nervosa
- Other health problems that might interfere with your ability to participate in the study
- Taking medications, other than monophasic birth control or monophasic (same dose every day) hormone replacement therapy and allergy medication
- Taking allergy medication for a period of time less than 6 months
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 |
|---|---|---|
| AspartameAlso: equal sweetenerThe morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998) | Dietary supplement | Aspartame |
| SucroseThe morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998) | Dietary supplement | Sucrose |
| SteviaThe morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998) | Dietary supplement | Stevia |
Primary outcome
Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels.
Time frame: 24 hours
Test whether preloads of tea and crackers with cream cheese sweetened with Stevia lover postprandial insulin levels compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by measuring blood insulin and glucose levels immediately prior to the lunch preload,immediately before lunch test meal, and at thirty minutes, one hour, and two hours after the lunch test meal.
2 secondary outcomes
Hedonic ratings (appearance, aroma, flavor, texture and palatability)with Stevia sweetener compared to Sucrose or Aspartame
Time frame: 24 hours
Satiating effects by examining food consumption
Time frame: 24 Hours
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 12 Feb 2016.
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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.
Stephen D. Anton, PhD principal investigator
Pennington Biomedical 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 Aspartame, Sucrose and Stevia in people with Obesity and Type 2 Diabetes, run by Pennington Biomedical 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 6 inclusion and 9 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 12 Feb 2016. 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?
Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels. (time frame: 24 hours). 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 12 Feb 2016.