OverweightNCT00475475
Sweetened Beverages and Food Intake
A study testing Fructose, glucose and non-caloric sweetener in people with Overweight and Obesity, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether beverages sweetened with fructose promote overconsumption of calories as compared to beverages sweetened with glucose or a non-caloric sweetener. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Fructose, glucose and non-caloric sweetener
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2011
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-25 years
- Body mass index: 20-25 kg/m2
- Weight stable to within 5 pounds for 6 months prior to entering the study
- Within 10 pounds of their lifetime maximum weight
- Ability to be admitted for 5 hours to the General Clinical Research Center of the University of Washington on three occasions
- Ability to provide informed written consent
- Willingness to consume only food provided by the Nutrition Research Kitchen of the University of Washington General Clinical Research Center for three periods of 8 days each
Who cannot join
- History of cardiovascular disease
- Presence of diabetes mellitus or impaired glucose tolerance (fasting glucose > 100 mg/dL)
- Presence of hypertension (blood pressure systolic/diastolic higher than 140/90)
- Presence of phenylketonuria
- Presence of fructose malabsorption or hereditary fructose intolerance
- Presence of another chronic or psychiatric illness
Show all 18Show fewer
- Use of anabolic steroids, glucocorticoids, warfarin, beta-blockers, antidepressants, or lipid-lowering agents
- Use of antibiotic drugs within 3 months of enrollment into the study
- Use of tobacco products
- Pregnancy or female subject not using contraception
- Regular intense exercise (> 3 hour per week)
- Vegetarian or extreme dietary preferences
- Alcohol consumption of more than 2 drinks per day
- Presence of eating disorder
- History of frequent attempts at weight loss
- Currently dieting or in a weight control program
- Recent blood donation or enrolled in other research which requires blood sampling
- Presence or history of anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington General Clinical Research Center
Seattle, Washington, 98195
About this study
The purpose of this study is to investigate whether beverages sweetened with fructose promote overconsumption of calories as compared to beverages sweetened with glucose or a non-caloric sweetener.
Read the detailed description
The rise in the prevalence of obesity and type 2 diabetes mellitus has been linked to an increased consumption of sugar- and particularly fructose-sweetened beverages. Preliminary evidence suggests that this could be partly explained by the fact that the reduction in the intake of solid food is inadequate to compensate for additional energy taken up from these beverages. In addition, the type of sugar used to sweeten a beverage might have a considerable impact on the body's ability to adjust food intake properly. In particular, the consumption of fructose has been reported to reduce diurnal plasma glucose, insulin, and leptin concentrations, but increase diurnal ghrelin concentrations as compared to isocaloric amounts of glucose. As the plasma concentrations of glucose, insulin, leptin, and ghrelin are involved in the regulation of food intake and energy expenditure, this might impair the longer-term ability of the body to match food intake and energy expenditure to stabilize body weight.
To investigate whether the regular consumption of fructose-sweetened beverages leads to an increase in total energy intake, the investigators will enroll healthy normal-weight subjects into a controlled diet study using a double-blind randomized cross-over design. Each subject will complete three diet periods: solid food plus a beverage sweetened with fructose (A), solid food plus a beverage sweetened with glucose (B), solid food plus a beverage sweetened with a non-caloric sweetener (C). During each period, subjects will be provided with all their food for 8 days. These diets will consist of meals freshly prepared using regular food items typically found in the American diet. Solid food will be provided in excess of what the subjects are estimated to require. Subjects will be asked to eat as much of this food as they need to feel comfortably satiated, and to return all excess foods to the Nutrition Research Kitchen of the University of Washington (UW) General Clinical Research Center (GCRC). This returned food will be weighed to assess precisely the amount and type of food eaten by the subjects on each day of these diet periods. In addition to this solid food, subjects will be asked to drink a certain amount of a lemonade sweetened with either fructose (A), glucose (B), or a non-caloric sweetener (C). In groups A and B, the subjects will consume 25% of their estimated daily calorie requirement in the form of these sugar sweetened beverages, while the drink in period C will be of the same volume.
Subjects will be admitted to the GCRC on the morning of day 9 of each diet period for the measurement of resting metabolic rate by means of indirect calorimetry and blood draws for the measurement of fasting plasma concentrations of adipogenic hormones and plasma lipids. Furthermore, we will administer a standardized breakfast and draw blood before and 0, 15, 30, 60, 90, and 120 minutes after this meal to measure the postprandial plasma concentrations of insulin, ghrelin, and satiety signals. Following the last postprandial blood draw, we will serve another meal to measure ad libitum food intake. Our hypothesis is that subjects will have more appetite and consume more food after they have consumed the fructose-sweetened beverage for 8 days.
Primary outcome measures of this study will be the total energy consumed during the periods A, B, and C; the reduction in the intake of solid foods in periods A and B as compared to period C; and energy uptake during the ad libitum meal served on day 9 of each diet period. Secondary outcome measures will be resting energy expenditure and plasma concentrations of satiety and adiposity signals.
- Conditions
- Overweight, Obesity
- Being tested
- Fructose, glucose, non-caloric sweetener
- Keywords
- Overweight, Obesity, Appetite, Dietary sugars, Fructose, Glucose, Leptin, Insulin, Ghrelin
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructoseBehavioural
25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
glucoseBehavioural
25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
non-caloric sweetenerBehavioural
25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fructose-sweetened beverage Subjects will be asked to drink 4 servings of a beverage sweetened with 100% fructose per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods). Receives: Behavioral: Fructose |
| 2 | Experimental | Glucose-sweetened beverage Subjects will be asked to drink 4 servings of a beverage sweetened with 100% glucose per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods). Receives: Behavioral: glucose |
| 3 | Placebo comparator | Beverage sweetened with a non-caloric sweetener Subjects will be asked to drink 4 servings of a beverage sweetened with a non-caloric sweetener per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods). Receives: Behavioral: non-caloric sweetener |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy consumed in the three diet periods.
Measured: 8 days in each period
Secondary outcomes (4)
Resting energy expenditure
Resting energy expenditure, as measured by indirect calorimetry.
Measured: After 8 days of each dietary phase
Fasting and postprandial plasma concentrations of satiety and adiposity signals.
We will measure the fasting plasma concentration of leptin, adiponectin, ghrelin, insulin, glucagon-like peptide 1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), amylin, and oxyntomodulin, and the change in these endpoints in the two ours after a standardized meal has been consumed.
Measured: After 8 days of each dietary phase
Fasting and postprandial plasma lipid and lipoprotein concentrations.
We will measure the fasting plasma concentrations of total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, and free fatty acids, as well as the changes in these endpoints in the two hours following a standardized meal. We will also measure the fatty acid composition in the plasma phospholipids, and the free fatty acid fraction of plasma.
Measured: After 8 days of each dietary phase
Fasting plasma concentrations of inflammatory mediators.
We will measure the fasting plasma concentrations of C-reactive protein (high sensitivity assay), interleukin-6 (IL-6), and the soluble tumor necrosis factor alpha receptors I \& II.
Measured: After 8 days of each dietary phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Principal investigator, Mario Kratz, University of Washington
- Investigators
- Mario Kratz, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475475
- Sponsor's protocol ID
- 28740-A
- Other IDs
- 05-8515-A 03
- Status last verified
- Apr 2012
- First submitted
- 16 May 2007
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Callahan HS, Weigle DS, Kratz M. No difference in ad libitum energy intake in healthy men and women consuming beverages sweetened with fructose, glucose, or high-fructose corn syrup: a randomized trial. Am J Clin Nutr. 2015 Dec;102(6):1373-80. doi: 10.3945/ajcn.115.116368. Epub 2015 Nov 4.
PubMed 26537945
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweetened Beverages and Food Intake
- ClinicalTrials.gov ID
- NCT00475475
- Acronym / sponsor ID
- 28740-A
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Appetite, Dietary sugars, Fructose, Glucose, Leptin, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- May 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 May 2007 (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 investigate whether beverages sweetened with fructose promote overconsumption of calories as compared to beverages sweetened with glucose or a non-caloric sweetener.
Detailed description
The rise in the prevalence of obesity and type 2 diabetes mellitus has been linked to an increased consumption of sugar- and particularly fructose-sweetened beverages. Preliminary evidence suggests that this could be partly explained by the fact that the reduction in the intake of solid food is inadequate to compensate for additional energy taken up from these beverages. In addition, the type of sugar used to sweeten a beverage might have a considerable impact on the body's ability to adjust food intake properly. In particular, the consumption of fructose has been reported to reduce diurnal plasma glucose, insulin, and leptin concentrations, but increase diurnal ghrelin concentrations as compared to isocaloric amounts of glucose. As the plasma concentrations of glucose, insulin, leptin, and ghrelin are involved in the regulation of food intake and energy expenditure, this might impair the longer-term ability of the body to match food intake and energy expenditure to stabilize body weight.
To investigate whether the regular consumption of fructose-sweetened beverages leads to an increase in total energy intake, the investigators will enroll healthy normal-weight subjects into a controlled diet study using a double-blind randomized cross-over design. Each subject will complete three diet periods: solid food plus a beverage sweetened with fructose (A), solid food plus a beverage sweetened with glucose (B), solid food plus a beverage sweetened with a non-caloric sweetener (C). During each period, subjects will be provided with all their food for 8 days. These diets will consist of meals freshly prepared using regular food items typically found in the American diet. Solid food will be provided in excess of what the subjects are estimated to require. Subjects will be asked to eat as much of this food as they need to feel comfortably satiated, and to return all excess foods to the Nutrition Research Kitchen of the University of Washington (UW) General Clinical Research Center (GCRC). This returned food will be weighed to assess precisely the amount and type of food eaten by the subjects on each day of these diet periods. In addition to this solid food, subjects will be asked to drink a certain amount of a lemonade sweetened with either fructose (A), glucose (B), or a non-caloric sweetener (C). In groups A and B, the subjects will consume 25% of their estimated daily calorie requirement in the form of these sugar sweetened beverages, while the drink in period C will be of the same volume.
Subjects will be admitted to the GCRC on the morning of day 9 of each diet period for the measurement of resting metabolic rate by means of indirect calorimetry and blood draws for the measurement of fasting plasma concentrations of adipogenic hormones and plasma lipids. Furthermore, we will administer a standardized breakfast and draw blood before and 0, 15, 30, 60, 90, and 120 minutes after this meal to measure the postprandial plasma concentrations of insulin, ghrelin, and satiety signals. Following the last postprandial blood draw, we will serve another meal to measure ad libitum food intake. Our hypothesis is that subjects will have more appetite and consume more food after they have consumed the fructose-sweetened beverage for 8 days.
Primary outcome measures of this study will be the total energy consumed during the periods A, B, and C; the reduction in the intake of solid foods in periods A and B as compared to period C; and energy uptake during the ad libitum meal served on day 9 of each diet period. Secondary outcome measures will be resting energy expenditure and plasma concentrations of satiety and adiposity signals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: FructoseFructose-sweetened beverage Subjects will be asked to drink 4 servings of a beverage sweetened with 100% fructose per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods). |
| 2 | Experimental | Behavioral: glucoseGlucose-sweetened beverage Subjects will be asked to drink 4 servings of a beverage sweetened with 100% glucose per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods). |
| 3 | Placebo comparator | Behavioral: non-caloric sweetenerBeverage sweetened with a non-caloric sweetener Subjects will be asked to drink 4 servings of a beverage sweetened with a non-caloric sweetener per day for 8 days, while consuming an ad libitum diet (same solid food for all three diet periods). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18-25 years
- Body mass index: 20-25 kg/m2
- Weight stable to within 5 pounds for 6 months prior to entering the study
- Within 10 pounds of their lifetime maximum weight
- Ability to be admitted for 5 hours to the General Clinical Research Center of the University of Washington on three occasions
Key exclusion criteria (18 listed)
- History of cardiovascular disease
- Presence of diabetes mellitus or impaired glucose tolerance (fasting glucose > 100 mg/dL)
- Presence of hypertension (blood pressure systolic/diastolic higher than 140/90)
- Presence of phenylketonuria
- Presence of fructose malabsorption or hereditary fructose intolerance
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 |
|---|---|---|
| Fructose25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener | Behavioural | 1 |
| glucose25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener | Behavioural | 2 |
| non-caloric sweetener25% of energy intake in the form of a fructose-sweetened beverage (arm 1), a glucose-sweetened beverage (arm 2), or an isovolumetric amount of a beverage sweetened with a non-caloric sweetener | Behavioural | 3 |
Primary outcome
Total energy consumed in the three diet periods.
Time frame: 8 days in each period
4 secondary outcomes
Resting energy expenditure
Time frame: After 8 days of each dietary phase
Fasting and postprandial plasma concentrations of satiety and adiposity signals.
Time frame: After 8 days of each dietary phase
Fasting and postprandial plasma lipid and lipoprotein concentrations.
Time frame: After 8 days of each dietary phase
Fasting plasma concentrations of inflammatory mediators.
Time frame: After 8 days of each dietary phase
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 2 May 2012.
- Derived from this study: PubMed 26537945Kuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Callahan HS, Weigle DS, Kratz M. No difference in ad libitum energy intake in healthy men and women consuming beverages sweetened with fructose, glucose, or high-fructose corn syrup: a randomized trial. Am J Clin Nutr. 2015 Dec;102(6):1373-80. doi: 10.3945/ajcn.115.116368. Epub 2015 Nov 4.
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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.
Mario Kratz, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose, glucose and non-caloric sweetener in people with Overweight and Obesity, run by University of Washington 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 7 inclusion and 18 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 2 May 2012. 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. Some participants in this study may receive a placebo. 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?
Total energy consumed in the three diet periods. (time frame: 8 days in each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00475475, which also lists 1 linked publication.
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 2 May 2012; AzTrials last refreshed its copy on 31 Oct 2026.