The DEB Pilot Study

Pennington Biomedical Research Center

Status: Completed

Conditions: Obesity; Nutritional Physiological Phenomena

Treatments: Other: Sugar Sweetened Solid Treatment; Other: Sugar Sweetened Beverage Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03190993

6218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Sugar Sweetened Solid Treatment

Active Comparator group

Description:

A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.

Treatment:

Other: Sugar Sweetened Solid Treatment

Sugar Sweetened Beverage Treatment

Active Comparator group

Description:

20 oz. carbonated sugar sweetened beverage. Added ingredients include: \~2.1g whey protein powder.

Treatment:

Other: Sugar Sweetened Beverage Treatment