NCT01987674

TerminatedPhase 1/2

Pre-meal Protein Drink Improve Glycemic Regulation

Lund University Source

Lund University

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

Dnr2013/239-31PMB

Study Type

interventional

Actual enrollment (reported)

35

Locations

1 country

Sites

1

Timeline

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

Brief Summary

The purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 35 participants
Study completion date: July 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 12, 2013
Actual (reported)
First Posted
November 19, 2013
Actual (reported)
Study Start
January 2014
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)
Study Completion
July 2015
Actual (reported)

Last Updated: May 12, 2016
Status Verified: May 2016
Last Update Submitted: May 11, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

HbA1c
Glycated hemoglobin
16 weeks

Secondary Outcomes (1)

Postprandial glycemia
16 weeks

Other Outcomes (1)

Homeostasis model assessment of insulin resistance (HOMA-IR)
16 weeks

Study Arms (2)

Pre-meal protein drink

EXPERIMENTAL

A dose of 100 ml is taken just before breakfast, lunch and dinner.

Dietary Supplement: Pre-meal protein drink

Water drink

PLACEBO COMPARATOR

A dose of 100 ml is taken just before breakfast, lunch and dinner.

Other: Water drink

Interventions

Pre-meal protein drinkDietary supplement

Pre-meal protein drink

Water drinkOther

Water drink

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age30 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

diagnosed type 2 diabetes mellitus according to WHO criteria (1999)
age between 30-80 years

Sponsors & Collaborators

Lund University
Otherlead
Landstinget i Kalmar Län
Othercollaborator

Study Sites (1)

Lindsdals hälsocentral

Kalmar, 39365, Sweden

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Enrollment

35 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate professor

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 19, 2013

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

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non well controlled diabetes with HbA1c-levels above 62 mmol/mol

You may not qualify if:

pregnant or risk of becoming pregnant
severe disease
psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation
liver disease
kidney malfunction (GFR \<60 or aspartate transaminase (ASAT)/alanine transaminase (ALT) two times higher than the normal interval

Contact the study team to confirm eligibility.

Primary Completion

July 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

Last Updated

May 12, 2016

Record last verified: 2016-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01987674
Data provider: ClinicalTrials.gov
Source updated: 2016-05-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:45 UTC

Locations

SE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Pre-meal protein drink

Water drink

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations