Nutritional Physiological Phenomena, Obesity
Conditions
Brief summary
The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.
Detailed description
Dose: Participants are to consume 1 unit per day of the study product. Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.
Interventions
OTHERSugar Sweetened Solid Treatment
Consume Sugar Sweetened Solid Treatment (product) daily.
OTHERSugar Sweetened Beverage Treatment
Consume Sugar Sweetened Beverage Treatment (product) daily.
Sponsors
Martin, Corby, K., M.D.
Owen T. Carmichael
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Intervention model description
A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 20 - 40
Exclusion criteria
* Diabetes (Type 1 or 2) * Prediabetes * Active cancer * Serious digestive disorders * Other conditions that affect metabolism or body weight * Uncontrolled Thyroid disorder (controlled = 6 months of medication) * Unable to consume study foods * Non- weight stable (more than 10 lbs weight gain or loss in last 6 months) * Pregnancy * Intentions of becoming pregnant in the next 2 months * Women who have undergone partial hysterectomy with intact ovary function * Current or past alcohol or drug abuse problem * Allergy or intolerance to study product ingredients. * Any other medical, psychiatric or behavioral factors that in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight | 1 month | Change from baseline in body weight at 1 month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugar Sweetened Solid Treatment A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.
Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily. | 10 |
| Sugar Sweetened Beverage Treatment 20 oz. carbonated sugar sweetened beverage. Added ingredients include: \
2.1g whey protein powder.
Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Sugar Sweetened Solid Treatment | Sugar Sweetened Beverage Treatment | Total |
|---|---|---|---|
| Age, Continuous | 36 years | 39 years | 37 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change From Baseline in Body Weight
Change from baseline in body weight at 1 month
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar Sweetened Solid Treatment | Change From Baseline in Body Weight | -0.325 kg | Standard Error 0.307 |
| Sugar Sweetened Beverage Treatment | Change From Baseline in Body Weight | 0.230 kg | Standard Error 0.307 |
p-value: =0.22Regression, Linear