Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing SugarsNCT02278042
A Comparison of the Neurocognitive and Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels in Adults Ages 20-60 Years Old
A study testing Beverage Consumption in people with Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing Sugars, run by Rippe Lifestyle Institute at 1 site in United States.
Trial summary
The purpose of this study is to investigate the acute and chronic effects of consumption fructose containing sugars and glucose in a real word setting when consumed in a manner and amount typical in the American diet. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing Sugars
- What is being tested?
- Beverage Consumption
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between the ages of 20-60 years of age.
- Body Mass Index (BMI) 21.0 - 35.0
Who cannot join
- More than a 3 percent change in weight within the 3 months prior to enrollment in the study.
- History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
- Currently taking a prescription medication for weight loss. If subject is willing to discontinue prescription medication(s) immediately and willing to refrain from taking medication(s) for duration of study, he/she may be enrolled after a four-week washout period.
- Currently taking any over-the-counter weight loss supplement(s). If subject is willing to discontinue supplement(s) immediately and willing to refrain from taking supplement(s) for duration of study, he/she may be enrolled after a two-week washout period.
- Currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous). If subject is willing to discontinue program immediately and willing to refrain from program for duration of study, he/she may be included after a two-week washout period.
- Diagnosed with prediabetes or frank diabetes (Type I or Type II).
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- History of major surgery within three months of enrollment.
- History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.
- Presence of implanted cardiac defibrillator or pacemaker.
- Uncontrolled hypertension/high blood pressure.
- History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy).
- Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
- History of inflammatory bowel disease
- History of fatty liver
- History or presence of cancer. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment completed more than 6 months prior to enrollment.
- History of clinically diagnosed eating disorders including anorexia nervosa, bulimia nervosa or binge eating disorder.
- Women who are pregnant, lactating or trying to become pregnant.
- Currently taking any prescription medication for less than 3 months.
- Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and/or unwilling to limit intake to less than 3 drinks per week during study participation.
- Known allergy to HFCS, sucrose, fructose or glucose.
- History of alcohol dependency
- Participation in another clinical trial within 30 days prior to enrollment.
- Lactose intolerance
- Currently smoking cigarettes
- Any clinically significant food allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rippe Lifestyle Institute
Celebration, Florida, 34747
About this study
The purpose of this study is to investigate the acute and chronic effects of consumption fructose containing sugars and glucose in a real word setting when consumed in a manner and amount typical in the American diet.
Read the detailed description
Detailed description (Why and How?) Fructose is known to be metabolized differently than the other common monosaccharides. In addition to the well know lipogenic effects, more recent evidence has shown that the acute changes in hormones and metabolic parameters that control appetite and energy regulation when with fructose consumption may promote caloric overconsumption and, in the long-term, weight gain and deteriorations in insulin sensitivity. However, fructose is rarely consumed in isolation, but instead is consumed in combination with other sugars (with glucose in the case of the two most common sources of fructose: high fructose corn syrup (HFCS) and sucrose, or as part of a mixed macronutrient meal. As such, the practical significance of these short-term findings of isolated monosaccharide consumption is limited.
AIM 1: investigate the response to ten weeks of daily consumption of typical levels of different fructose containing sugars and glucose on measures of glucose and insulin metabolism.
AIM 2: To investigate whether ten weeks of daily consumption changes the fat content of the liver, skeletal muscles or abdomen.
- Conditions
- Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing Sugars
- Being tested
- Beverage Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage ConsumptionOther
| Study group | Role | What they receive |
|---|---|---|
| 9% Fuctose | Active comparator | Milk Sweetened with fructose in an amount that the added fructose contributes 9% of the calories required for weight maintenance. Receives: Other: Beverage Consumption |
| 18% Sucrose | Active comparator | Milk Sweetened with sucrose in an amount that the added sucrose contributes 18% of the calories required for weight maintenance. Receives: Other: Beverage Consumption |
| 18% High fructose corn syrup | Active comparator | Milk Sweetened with High fructose corn syrup (HFCS) in an amount that the added HFCS contributes 18% of the calories required for weight maintenance. Receives: Other: Beverage Consumption |
| 9% Glucose | Active comparator | Milk Sweetened with glucose in an amount that the added glucose contributes 9% of the calories required for weight maintenance. Receives: Other: Beverage Consumption |
| Unsweetened Milk | Active comparator | Unsweetened milk consumed in amount the contributes 18% of the calories required for weight maintenance. Receives: Other: Beverage Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose tolerance
Change in glucose Area Under the Curve (AUC) in response to a standard 2 hour Oral Glucose Tolerance Test
Measured: 10 weeks (Baseline and week 10)
Change in Insulin Sensitivity
Change in 1) insulin AUC in response to a standard 2 hour Oral Glucose and Matsuda Insulin Sensitivity Index
Measured: 10 weeks (Baseline and week 10)
Secondary outcomes (4)
Change in fat content of the liver
Change in fat content of the liver as determined by Magnetic Resonance Spectroscopy (MRS)
Measured: 10 weeks (baseline and Week 10)
Change in fat content of the abdomen
Change in fat content of the abdomen as determined by MRS
Measured: 10 weeks (baseline and Week 10)
Change in fat content of the skeletal muscles
Change in fat content of the Vastus Lateralis and Gluteus Maximum as determined by MRI.
Measured: 10 weeks (baseline and Week 10)
Change in hypothalamic activity
Change in hypothalamic activity in response to consumption of test beverages consumed as part of a standardized, mixed nutrient meal will be measured by functional MRI. Changes from baseline (mean percent signal change) will be determined after 10 weeks of daily consumption of the test beverage as part of the usual diet
Measured: 10 weeks (baseline and Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing SugarsStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rippe Lifestyle Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278042
- Sponsor's protocol ID
- 20131024
- Status last verified
- Apr 2015
- First submitted
- 27 Oct 2014
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Neurocognitive and Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels in Adults Ages 20-60 Years Old
- ClinicalTrials.gov ID
- NCT02278042
- Acronym / sponsor ID
- 20131024
- Conditions
- Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing Sugars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Rippe Lifestyle InstituteIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- First posted
- 29 Oct 2014 (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 the acute and chronic effects of consumption fructose containing sugars and glucose in a real word setting when consumed in a manner and amount typical in the American diet.
Detailed description
Detailed description (Why and How?) Fructose is known to be metabolized differently than the other common monosaccharides. In addition to the well know lipogenic effects, more recent evidence has shown that the acute changes in hormones and metabolic parameters that control appetite and energy regulation when with fructose consumption may promote caloric overconsumption and, in the long-term, weight gain and deteriorations in insulin sensitivity. However, fructose is rarely consumed in isolation, but instead is consumed in combination with other sugars (with glucose in the case of the two most common sources of fructose: high fructose corn syrup (HFCS) and sucrose, or as part of a mixed macronutrient meal. As such, the practical significance of these short-term findings of isolated monosaccharide consumption is limited.
AIM 1: investigate the response to ten weeks of daily consumption of typical levels of different fructose containing sugars and glucose on measures of glucose and insulin metabolism.
AIM 2: To investigate whether ten weeks of daily consumption changes the fat content of the liver, skeletal muscles or abdomen.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 9% Fuctose | Active comparator | Other: Beverage ConsumptionMilk Sweetened with fructose in an amount that the added fructose contributes 9% of the calories required for weight maintenance. |
| 18% Sucrose | Active comparator | Other: Beverage ConsumptionMilk Sweetened with sucrose in an amount that the added sucrose contributes 18% of the calories required for weight maintenance. |
| 18% High fructose corn syrup | Active comparator | Other: Beverage ConsumptionMilk Sweetened with High fructose corn syrup (HFCS) in an amount that the added HFCS contributes 18% of the calories required for weight maintenance. |
| 9% Glucose | Active comparator | Other: Beverage ConsumptionMilk Sweetened with glucose in an amount that the added glucose contributes 9% of the calories required for weight maintenance. |
| Unsweetened Milk | Active comparator | Other: Beverage ConsumptionUnsweetened milk consumed in amount the contributes 18% of the calories required for weight maintenance. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female between the ages of 20-60 years of age.
- Body Mass Index (BMI) 21.0 - 35.0
Key exclusion criteria (25 listed)
- More than a 3 percent change in weight within the 3 months prior to enrollment in the study.
- History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
- Currently taking a prescription medication for weight loss. If subject is willing to discontinue prescription medication(s) immediately and willing to refrain from taking medication(s) for duration of study, he/she may be enrolled after a four-week washout period.
- Currently taking any over-the-counter weight loss supplement(s). If subject is willing to discontinue supplement(s) immediately and willing to refrain from taking supplement(s) for duration of study, he/she may be enrolled after a two-week washout period.
- Currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous). If subject is willing to discontinue program immediately and willing to refrain from program for duration of study, he/she may be included after a two-week washout period.
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 |
|---|---|---|
| Beverage Consumption | Other | 18% High fructose corn syrup, 18% Sucrose, 9% Fuctose, 9% Glucose, Unsweetened Milk |
Primary outcome
Change in glucose tolerance
Time frame: 10 weeks (Baseline and week 10)
Change in glucose Area Under the Curve (AUC) in response to a standard 2 hour Oral Glucose Tolerance Test
Change in Insulin Sensitivity
Time frame: 10 weeks (Baseline and week 10)
Change in 1) insulin AUC in response to a standard 2 hour Oral Glucose and Matsuda Insulin Sensitivity Index
4 secondary outcomes
Change in fat content of the liver
Time frame: 10 weeks (baseline and Week 10)
Change in fat content of the abdomen
Time frame: 10 weeks (baseline and Week 10)
Change in fat content of the skeletal muscles
Time frame: 10 weeks (baseline and Week 10)
Change in hypothalamic activity
Time frame: 10 weeks (baseline and Week 10)
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 10 Apr 2015.
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 Beverage Consumption in people with Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing Sugars, run by Rippe Lifestyle Institute 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 25 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose tolerance (time frame: 10 weeks (Baseline and week 10)). 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 10 Apr 2015.