Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric SweetenersNCT02252952
The Effect of Sugar Sweetened and Diet Beverages Consumed as Part of a Weight-Maintenance Diet on Fat Storage
A study testing Beverage Consumption in people with Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric Sweeteners, run by Rippe Lifestyle Institute at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of consumption of sugar sweetened and diet beverages on overall fat mass and the fat mass of various tissues implicated in the dysregulation of glucose metabolism. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric Sweeteners
- What is being tested?
- Beverage Consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female
- Age between 20-50 years
- Body Mass Index (BMI) 21.0 to less than 30.0
- Consumer of at least one sugar sweetened or diet beverage per day
Who cannot join
- More than a 3% change in weight within the 3 months prior to enrollment in the study.
- Menstrual cycle that is not regular or post-menopausal
- Continued consumption of 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.
- Continued consumption of 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.
- Continued enrollment 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.
- 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.
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- Diagnosed with Type I or Type II diabetes or prediabetes.
- 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.
- Hypertension/high blood pressure, or any hypertensive medication.
- 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.
- Any change in prescription medication within 3 months prior to enrollment
- Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week.
- Known allergy to high fructose corn syrup, sucrose, fructose or glucose.
- History of alcohol dependency
- Extreme exercise regimes (eg. Marathon or triathlon)
- Currently smoking cigarettes
- 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 Effects of Sugar Sweetened Beverages (SSBs), Diet Beverages and Water on Weight, Body Composition, Liver and Muscle Fat Infiltration, Visceral Fat, Neurocognitive Function, Blood Lipids, Insulin Resistance and Hydration Status in Healthy Weight and Overweight, Premenopausal Females Aged 20-50
The purpose of this study is to investigate the effects of consumption of sugar sweetened and diet beverages on overall fat mass and the fat mass of various tissues implicated in the dysregulation of glucose metabolism. In addition, hypothalamic activity will also be investigated after acute exposure to sugar sweetened and diet beverages, and again after 6 months of daily consumption.
Read the detailed description
Excess fat deposition in skeletal muscle and the liver have both been implicated in the metabolic dysregulation that leads to type II diabetes. It has been shown that daily consumption of sugar sweetened beverages can lead to increases in the fat mass of these organs. However, little appreciation was given for the effect of overall changes in weight and fat mass or how applicable the doses provided may be for how sugar sweetened beverages are typically consumed.
In addition, it has recently been shown that sugars can suppress hypothalamic activity and alter patterns of brain connectivity in regions known to be involved in homeostasis and reward aspects of food intake. However, these observations were made after large doses or sugars not commonly consumed in isolation from other sugars or other macronutrients. Foods containing non-caloric sweeteners have also been suggested to suppress hypothalamic activity due to the disconnect between perceived sweetness and calories consumed.
AIM 1: To investigate the response to six months of daily consumption of sugar sweetened or diet beverages as part of a weight-stable structured diet on whole body fat content, but also specifically fat content of the liver, skeletal muscles the abdomen.
AIM 2: To investigate hypothalamic activity after acute exposure to sugar sweetened and or diet beverages, and whether chronic exposure for 6 months induces any changes in hypothalamic activity.
- Being tested
- Beverage Consumption
- Keywords
- Sugar Sweetened Beverages, Diet Beverages, ectopic fat, Functional MRI
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 |
|---|---|---|
| Sugar Sweetened Beverages | Experimental | Any beverage from a range of caffeine free, sugar sweetened drinks. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months. Receives: Other: Beverage Consumption |
| Diet Beverage | Experimental | Any beverage from a range of caffeine free drinks sweetened with non-caloric sweetener. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months. Receives: Other: Beverage Consumption |
| Water | Active comparator | 12 oz of water. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months. Receives: Other: Beverage Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Storage
Changes in total body adiposity (body fat percentage and fat mass) as measured by Dual X Ray Absorbance after 6 months of daily consumption of sugar sweetened or diet beverages as part of a weight-maintenance structured diet. Changes in fat content of skeletal muscle (via MRI) and liver and the abdomen (both MRS) will also be assessed.
Measured: Baseline and 6 Months
Secondary outcomes (1)
Hypothalamic Activity
Hypothalamic activity in response to consumption of sugar sweetened or diet 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 6 months of daily consumption of the test beverage
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startFeb 2013
- Primary completionMar 2015 (estimated)
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 Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric SweetenersStudies 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
- None (open label)
- Enrolment
- 99 participants (estimated)
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
- NCT02252952
- Sponsor's protocol ID
- 1136635
- Status last verified
- Dec 2014
- First submitted
- 26 Sep 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
PubMed 32449201
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Sugar Sweetened Beverages (SSBs), Diet Beverages and Water on Weight, Body Composition, Liver and Muscle Fat Infiltration, Visceral Fat, Neurocognitive Function, Blood Lipids, Insulin Resistance and Hydration Status in Healthy Weight and Overweight, Premenopausal Females Aged 20-50
- ClinicalTrials.gov ID
- NCT02252952
- Acronym / sponsor ID
- 1136635
- Keywords
- Sugar Sweetened Beverages, Diet Beverages, ectopic fat, Functional MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Rippe Lifestyle InstituteIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2015 (estimated)
- First posted
- 30 Sep 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 effects of consumption of sugar sweetened and diet beverages on overall fat mass and the fat mass of various tissues implicated in the dysregulation of glucose metabolism. In addition, hypothalamic activity will also be investigated after acute exposure to sugar sweetened and diet beverages, and again after 6 months of daily consumption.
Detailed description
Excess fat deposition in skeletal muscle and the liver have both been implicated in the metabolic dysregulation that leads to type II diabetes. It has been shown that daily consumption of sugar sweetened beverages can lead to increases in the fat mass of these organs. However, little appreciation was given for the effect of overall changes in weight and fat mass or how applicable the doses provided may be for how sugar sweetened beverages are typically consumed.
In addition, it has recently been shown that sugars can suppress hypothalamic activity and alter patterns of brain connectivity in regions known to be involved in homeostasis and reward aspects of food intake. However, these observations were made after large doses or sugars not commonly consumed in isolation from other sugars or other macronutrients. Foods containing non-caloric sweeteners have also been suggested to suppress hypothalamic activity due to the disconnect between perceived sweetness and calories consumed.
AIM 1: To investigate the response to six months of daily consumption of sugar sweetened or diet beverages as part of a weight-stable structured diet on whole body fat content, but also specifically fat content of the liver, skeletal muscles the abdomen.
AIM 2: To investigate hypothalamic activity after acute exposure to sugar sweetened and or diet beverages, and whether chronic exposure for 6 months induces any changes in hypothalamic activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar Sweetened Beverages | Experimental | Other: Beverage ConsumptionAny beverage from a range of caffeine free, sugar sweetened drinks. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months. |
| Diet Beverage | Experimental | Other: Beverage ConsumptionAny beverage from a range of caffeine free drinks sweetened with non-caloric sweetener. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months. |
| Water | Active comparator | Other: Beverage Consumption12 oz of water. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or Female
- Age between 20-50 years
- Body Mass Index (BMI) 21.0 to less than 30.0
- Consumer of at least one sugar sweetened or diet beverage per day
Key exclusion criteria (26 listed)
- More than a 3% change in weight within the 3 months prior to enrollment in the study.
- Menstrual cycle that is not regular or post-menopausal
- Continued consumption of 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.
- Continued consumption of 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.
- Continued enrollment 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 | Diet Beverage, Sugar Sweetened Beverages, Water |
Primary outcome
Fat Storage
Time frame: Baseline and 6 Months
Changes in total body adiposity (body fat percentage and fat mass) as measured by Dual X Ray Absorbance after 6 months of daily consumption of sugar sweetened or diet beverages as part of a weight-maintenance structured diet. Changes in fat content of skeletal muscle (via MRI) and liver and the abdomen (both MRS) will also be assessed.
1 secondary outcome
Hypothalamic Activity
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Derived from this study: PubMed 32449201Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
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 Beverage Consumption in people with Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric Sweeteners, 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 4 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 16 Dec 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?
Results are not available in the source record.
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?
Fat Storage (time frame: Baseline and 6 Months). 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 NCT02252952, 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 16 Dec 2014.