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Status unknownNCT01776099DiNA-S DiNA-FUpdated Jun 24, 2020

Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes

An interventional study of Dietary supplement (4 arms, 2 active, 2 placebo) in Type 2 Diabetes, sponsored by German Institute of Human Nutrition. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2020-06-24.

Sponsored by German Institute of Human Nutrition · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • type 2 diabetes
  • nutrition
  • fibers
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's planned enrollment of 60 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

German Institute of Human Nutrition is the lead sponsor of 34 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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...)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    pure galactose

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

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

  • Placebo comparator
    pure palatinose

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

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

  • Placebo comparator
    soluble non-fermentable fibers

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

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

  • Active comparator
    non-soluble non-fermentable fibers

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

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

Interventions

  • Dietary supplementDietary supplement (4 arms, 2 active, 2 placebo)
06

What researchers measure

Primary outcomes

  1. metabolic improvement of type 2 diabetes

    metabolic improvement of type 2 diabetes, as to be shown via hyperinsulinemic-euglycaemic clamp, mixed-meal test and daily demand of insulin units

    Time frame: 4 weeks

07

Study locations

1 site
  • Charité-Klinikum Benjamin Franklin
    Berlin, 12203, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01776099
Lead sponsor
German Institute of Human Nutrition
Collaborators
Firma Rettenmeier & Söhne (Company), German Center for Diabetes Research
Responsible party
Prof. Dr. med. Andreas F. H. Pfeiffer (Director of the Department for Clinical Nutrition, German Institute of Human Nutrition) — Principal investigator
First posted
Jan 25, 2013
Start date
Nov 2012
Primary completion
Oct 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jun 24, 2020

Study contacts

Andreas F.H. Pfeiffer, Prof. Dr. med.
principal investigator · German Institute for Human Nutrition

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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