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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT00475475
Study groupRoleWhat they receive
1ExperimentalFructose-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
2ExperimentalGlucose-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
3Placebo comparatorBeverage 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.

  1. Total energy consumed in the three diet periods.

    Measured: 8 days in each period

Secondary outcomes (4)
  1. Resting energy expenditure

    Resting energy expenditure, as measured by indirect calorimetry.

    Measured: After 8 days of each dietary phase

  2. 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

  3. 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

  4. 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.

  1. First posted21 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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)
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

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.

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