NCT05456672

Brief Summary

The purpose of this study is to assess the impact of combining starch rich foods with low pH foods on the glycemic response to meals

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

July 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

July 7, 2022

Last Update Submit

February 3, 2023

Conditions

Postprandial Glycemia

Keywords

DigestionStarchGlycemic Index

Outcome Measures

Primary Outcomes (1)

  • Glycemic response

    Measurement of postprandial glucose concentrations

    12 days

Secondary Outcomes (5)

  • Composition of non standardized meals

    10 days

  • Adherence to food combination recommendations

    3 days

  • Salivary alpha-amylase activity

    Baseline

  • AMY 1 copy number

    Baseline

  • Dietary patterns

    Baseline

Study Arms (1)

Dietary intervention

EXPERIMENTAL

Dietary intervention using standardized test meals

Other: Test meals and food baskets

Interventions

Test meals and food basketsOTHER

Interventional dietary study using standardized test meals and personalized food baskets to investigate the impact of food combination on the glycemic response. The study period is organized as follows: (Day 1: Continuous blood glucose monitoring system (CGM) activation) Days 2 and 3: Two standardized daily menus (breakfast, lunch, afternoon snack and dinner) provided on a randomized crossover basis. Days 4 to 7: four standardized test meals, participants will be asked to substitute one meal each day (lunch or dinner) for a test meal according to a pre-defined randomization plan. Days 8 to 10: Participants will be asked to prepare all meals using a food basket containing a mix of standardized and personal preference items. Days 11 to 13: Participants will be asked to prepare all meals using a food basket containing a mix of standardized and personal preference items and following dietary recommendations developed by the study staff. (Day 14: CGM sensor removed)

Dietary intervention

Eligibility Criteria

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

You may qualify if:

  • Subject has given written informed consent
  • Subject is available to participate in the study sessions on the proposed dates.

You may not qualify if:

  • Subject has an allergy or intolerance to any food and/or ingredient in the study meals
  • Body mass index ≤ 18.5 kg/m2 or ≥ 30.0 kg/m2.
  • Diagnosed mouth, throat or active gastrointestinal pathology that may affect normal ingestion and digestion of food.
  • History of pancreatic disease
  • Subject is immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last year).
  • Subject has Type 1 or Type 2 diabetes mellitus or pre-diabetes.
  • Subject has a history of drug and/or alcohol abuse at the time of enrolment.
  • Subject is currently taking medication that can effect glucose metabolism and/or normal gastrointestinal function.
  • Subject is currently participating in another study, or plans to participate in another study during the study period.
  • Women of child-bearing potential who do not use an acceptable method of contraception.
  • Pregnant or nursing (lactating) women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Santo Espírito da Ilha Terceira

Angra do Heroísmo, Azores, 9700-049, Portugal

Location

TERInov

Angra do Heroísmo, Azores, 9700-702, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 13, 2022

Study Start

July 18, 2022

Primary Completion

September 5, 2022

Study Completion

September 5, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(2)