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The Effect of Sugar Sweetened and Diet Beverages Consumed as Part of a Weight-Maintenance Diet on Fat Storage

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ClinicalTrials.gov Identifier: NCT02252952
Recruitment Status : Unknown
Verified December 2014 by Rippe Lifestyle Institute.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2014
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Rippe Lifestyle Institute

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric Sweeteners Other: Beverage Consumption Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : February 2013
Estimated Primary Completion Date : March 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sugar Sweetened Beverages
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.
 Other: Beverage Consumption
Experimental: Diet Beverage
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.
 Other: Beverage Consumption
Active Comparator: Water
12 oz of water. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.
 Other: Beverage Consumption


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hypothalamic Activity [ Time Frame: 6 Months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252952


Locations
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United States, Florida
Rippe Lifestyle Institute
Celebration, Florida, United States, 34747
Sponsors and Collaborators
Rippe Lifestyle Institute
Investigators
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Principal Investigator: James M Rippe, MD Rippe Lifestyle Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rippe Lifestyle Institute
ClinicalTrials.gov Identifier: NCT02252952    
Other Study ID Numbers: 1136635
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Keywords provided by Rippe Lifestyle Institute:
Sugar Sweetened Beverages, Diet Beverages, ectopic fat, Functional MRI