Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes (DiNA-S DiNA-F)

German Institute of Human Nutrition

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT01776099

DiNA-S DiNA-F

Details and patient eligibility

About

In animal models and retrospective studies, certain food components such as sugars and fiber have been detected as potential agents to influence development and progress of type 2 diabetes.

The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in patients with long-term type 2 diabetes and intensive insulin treatment.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes, insulin-dependent
• high insulin resistance

Exclusion criteria

• accompanying disease, medication or metabolic disorder, which interact with glucose metabolism or eating behavior (e.g. renal insufficiency, major cardial insuffiency, untreated hypothyreosis, corticoid treatment, depression and other psychiatric disorders...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

pure galactose

Active Comparator group

Description:

5 grams of galactose, three times a day with the main meals, duration: 4 weeks

Treatment:

Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

pure palatinose

Placebo Comparator group

Description:

5 grams of palatinose, three times a day with the main meals, duration: 4 weeks

Treatment:

Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

soluble non-fermentable fibers

Placebo Comparator group

Description:

5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks

Treatment:

Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

non-soluble non-fermentable fibers

Active Comparator group

Description:

5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks

Treatment:

Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)