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

NCT02252952 | Unknown

• 1 other identifier: 1136635
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric Sweeteners

Keywords

Sugar Sweetened Beverages, Diet Beverages, ectopic fat, Functional MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 Months

Secondary Outcomes (1)

• Hypothalamic Activity

  6 Months

Study Arms (3)

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.

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.

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.

Other: Beverage Consumption

Interventions

Beverage Consumption OTHER

Diet Beverage; Sugar Sweetened Beverages; Water

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rippe Lifestyle Institute: lead

Study Sites (1)

Rippe Lifestyle Institute

Celebration, Florida, 34747, United States

Location

Related Publications (1)

• 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.

  PMID: 32449201 DERIVED

Study Officials

• James M Rippe, MD

  Rippe Lifestyle Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: February 1, 2013
• Primary Completion: March 1, 2015
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)