Intestinal Ketone Bodies Interfere With the Glycemic Control

NCT05154461 | Completed

• 1 other identifier: Ket001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The ketone body (KB) ß-hydroxybutyrate will be given to eight fasting healthy volunteers of both sexes in order to observe the effects after an oral glucose tolerance test (OGTT) over 2 h. Then, a standard lunch will be served at 12.00, as well as an afternoon snack at 15.00. Each participant will be its own control and participates in a randomised two-way cross over design; the KB are released in the stomach-duodenum, or in the ileum-colon. Peripheral blood samples are taken for endpoint GLP-1 analyses.

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC) of plasma GLP-1 over 120 minutes.

  BHB is given in the upper GI tract (alginate encapsulation) or at the distal GI tract (pea-protein encapsulated). AUC of the plasma GLP-1 concentration (pmol x min) stimulated by an OGTT (75 g glucose per-os given).

  120 minutes (AUC)

Study Arms (1)

GLP-1 in relation to the 2 major BHB release sites

EXPERIMENTAL

The magnitude of plasma GLP-1 following an OGTT (75g glucose per os) when beta-hydroxybutyrate (BHB) is released either at an upper gastrointestinal site (alginate encapsulation), or at distal gastrointestinal site (pea-protein encapsulation). BHB is given per-os in a single dose of 18g, plus 2 g encapsulation material; totally 20 g.

Other: Alginate; Other: Pea-protein

Interventions

Alginate OTHER

BHB covered in alginate will be realised in stomach-duodenum

GLP-1 in relation to the 2 major BHB release sites

Pea-protein OTHER

BHB covered in pea-protein will be released in ileum-colon

GLP-1 in relation to the 2 major BHB release sites

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years of both sexes
• healthy and without prescribed pharmaceuticals (anticonceptive drugs allowed)
• no symptoms associated with gastrointestinal dysfunction

You may not qualify if:

• pregnancy or breastfeeding
• allergy towards standard meals or treatment
• previous substance abuse

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital

Gothenburg, SE41345, Sweden

Location

MeSH Terms

Interventions

Alginates; Pea Proteins

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates; Plant Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lars Fändriks, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: December 13, 2021
• Study Start: December 5, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From the 12th of October 2021, to end of 2022.
• Access Criteria: Laboratory of Surgical Research, Sahlgrenska Universityhospital, Gothenburg, Sweden

Locations

SE (1)