ObesityNCT01797042
A Comparison of the Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels in Adults Aged 20-60 Years Old
A study testing Dietary Compliance in people with Obesity, 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
- Obesity
- What is being tested?
- Dietary Compliance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jul 2014
- 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
- Body Mass Index (BMI) 21.0 -33.0
Who cannot join
- More than a 3% change in weight within the 3 months prior to enrollment in the study.
- Currently smoking cigarettes
- Currently taking any prescription medication for less than 3 months.
- Currently taking a prescription medication for weight loss (4 week wash out period required).
- Currently taking any over-the-counter weight loss supplement/s (2 week wash out period required).
- History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months.
Show all 24Show fewer
- Diagnosed with Type I or Type II diabetes or prediabetes.
- 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.
- 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 (except for successfully resected basal cell carcinoma of the skin 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.
- History of alcohol dependency
- 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.
- Lactose intolerance
- Known allergy to HFCS, sucrose, fructose or glucose.
- Any clinically significant food allergy
- Participation in another clinical trial within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rippe Lifestyle Institute
Celebration, Florida, 34747
About this study
Official title: A Comparison of the Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels on Liver and Muscle Fatty Infiltration, Insulin Resistance, Glucose, Insulin, Leptin, Ghrelin, Postprandial Triglycerides, LDL Particle Size, Uric Acid and Appetite in Adults Aged 20-60 Years Old
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
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. 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 different fructose containing sugars and glucose at typical intake levels on various metabolic parameters and on fat content of the liver and skeletal muscle.
AIM 2: To investigate whether ten weeks of daily consumption changes the acute metabolic response when these sugars are consumed as part as mixed nutrient meals.
- Conditions
- Obesity
- Being tested
- Dietary Compliance
- Keywords
- Fructose, High fructose corn syrup, Energy regulation, Ectopic fat, Understanding, potential
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary ComplianceBehavioural
Incorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks
| Study group | Role | What they receive |
|---|---|---|
| Fructose 9% | Active comparator | Sugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance Receives: Behavioral: Dietary Compliance |
| Glucose 9% | Active comparator | Sugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance Receives: Behavioral: Dietary Compliance |
| High fructose corn syrup 18% | Active comparator | Sugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance Receives: Behavioral: Dietary Compliance |
| Sucrose 18% | Active comparator | Sugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance Receives: Behavioral: Dietary Compliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid)
Measured: Baseline and 10 weeks
Changes in fat content of skeletal muscle and liver
Measured: Baseline and 10 weeks
Secondary outcomes (3)
Change in body mass and body composition
Measured: Baseline and 10 weeks
Change in fasting levels of biomarkers associated with obesity (glucose, insulin, C Reactive Protein (CRP), lipid panel)
Measured: Baseline and 10 weeks
Change in glucose tolerance
Measured by the area under the plasma curve for 2 hours after an oral glucose challenge (75g glucose)
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionJul 2014
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 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rippe Lifestyle Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James M Rippe, MD, Principal investigator, Rippe Lifestyle Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797042
- Sponsor's protocol ID
- 20122091
- Status last verified
- Sep 2014
- First submitted
- 20 Feb 2013
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Angelopoulos TJ, Lowndes J, Sinnett S, Rippe JM. Fructose containing sugars do not raise blood pressure or uric acid at normal levels of human consumption. J Clin Hypertens (Greenwich). 2015 Feb;17(2):87-94. doi: 10.1111/jch.12457. Epub 2014 Dec 15.
PubMed 25496265
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels on Liver and Muscle Fatty Infiltration, Insulin Resistance, Glucose, Insulin, Leptin, Ghrelin, Postprandial Triglycerides, LDL Particle Size, Uric Acid and Appetite in Adults Aged 20-60 Years Old
- ClinicalTrials.gov ID
- NCT01797042
- Acronym / sponsor ID
- 20122091
- Conditions
- Obesity
- Keywords
- Fructose, High fructose corn syrup, Energy regulation, Ectopic fat, Understanding, potential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Rippe Lifestyle InstituteIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Feb 2013 (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
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. 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 different fructose containing sugars and glucose at typical intake levels on various metabolic parameters and on fat content of the liver and skeletal muscle.
AIM 2: To investigate whether ten weeks of daily consumption changes the acute metabolic response when these sugars are consumed as part as mixed nutrient meals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fructose 9% | Active comparator | Behavioral: Dietary ComplianceSugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance |
| Glucose 9% | Active comparator | Behavioral: Dietary ComplianceSugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance |
| High fructose corn syrup 18% | Active comparator | Behavioral: Dietary ComplianceSugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance |
| Sucrose 18% | Active comparator | Behavioral: Dietary ComplianceSugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) 21.0 -33.0
Key exclusion criteria (24 listed)
- More than a 3% change in weight within the 3 months prior to enrollment in the study.
- Currently smoking cigarettes
- Currently taking any prescription medication for less than 3 months.
- Currently taking a prescription medication for weight loss (4 week wash out period required).
- Currently taking any over-the-counter weight loss supplement/s (2 week wash out period required).
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 |
|---|---|---|
| Dietary ComplianceIncorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks | Behavioural | Fructose 9%, Glucose 9%, High fructose corn syrup 18%, Sucrose 18% |
Primary outcome
Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid)
Time frame: Baseline and 10 weeks
Changes in fat content of skeletal muscle and liver
Time frame: Baseline and 10 weeks
3 secondary outcomes
Change in body mass and body composition
Time frame: Baseline and 10 weeks
Change in fasting levels of biomarkers associated with obesity (glucose, insulin, C Reactive Protein (CRP), lipid panel)
Time frame: Baseline and 10 weeks
Change in glucose tolerance
Time frame: Baseline and 10 weeks
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 30 Sep 2014.
- Derived from this study: PubMed 25496265Angelopoulos TJ, Lowndes J, Sinnett S, Rippe JM. Fructose containing sugars do not raise blood pressure or uric acid at normal levels of human consumption. J Clin Hypertens (Greenwich). 2015 Feb;17(2):87-94. doi: 10.1111/jch.12457. Epub 2014 Dec 15.
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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.
James M Rippe, MD principal investigator
Rippe Lifestyle Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Compliance in people with Obesity, 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 1 inclusion and 24 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 30 Sep 2014. 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?
Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid) (time frame: Baseline and 10 weeks). 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?
On the ClinicalTrials.gov record for NCT01797042, 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 30 Sep 2014.