NCT06589856

Brief Summary

To investigate whether there is a linear dose-response relationship between oral lactate and its effects on gut hormone secretion, motility, and appetite. Hypothesis Oral lactate administration affects gut hormone secretion, insulin levels, motility, appetite sensation and the amount of food intake in a linear dose-response relationship.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 6, 2024

Last Update Submit

September 6, 2024

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Difference in mean insulin concentration

    Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20.

    60 minutes

Secondary Outcomes (8)

  • Difference in blood glucose

    0-180 minutes after the intervention

  • Difference in GLP-1

    0-180 minutes after the intervention

  • Difference in GIP

    0-180 minutes after the intervention

  • Difference in LEAP2

    0-180 minutes after the intervention

  • Difference in glucagon

    0-180 minutes after the intervention

  • +3 more secondary outcomes

Study Arms (4)

CTR

PLACEBO COMPARATOR
Dietary Supplement: PlaceboDietary Supplement: LAC5Dietary Supplement: LAC10Dietary Supplement: LAC20

LAC5

EXPERIMENTAL
Dietary Supplement: PlaceboDietary Supplement: LAC5Dietary Supplement: LAC10Dietary Supplement: LAC20

LAC10

EXPERIMENTAL
Dietary Supplement: PlaceboDietary Supplement: LAC5Dietary Supplement: LAC10Dietary Supplement: LAC20

LAC20

EXPERIMENTAL
Dietary Supplement: PlaceboDietary Supplement: LAC5Dietary Supplement: LAC10Dietary Supplement: LAC20

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo (300 mL salt water, NaCl) = CTR

CTRLAC10LAC20LAC5
LAC5DIETARY_SUPPLEMENT

5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5

CTRLAC10LAC20LAC5
LAC10DIETARY_SUPPLEMENT

10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10

CTRLAC10LAC20LAC5
LAC20DIETARY_SUPPLEMENT

20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20

CTRLAC10LAC20LAC5

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Written and oral consent
  • Healthy

You may not qualify if:

  • HbA1c \> 39
  • Taking medicine
  • Any diseases
  • Allergy to paracetamol
  • Doesn't speak or understand Danish.
  • Special diets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Aarhus, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Esben Sondergaard

    Aarhus University, Steno Diabetes Center Aarhus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esben Søndergaard

CONTACT

004528730943esben.sondergaard@clin.au.dk

Jens H Voigt

CONTACT

004526395294Jens.voigt@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized single-blinded, placebo-controlled crossover study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

DK(1)