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

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.

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.