Mediterranean Style Diet and Low Glycemic Responses

NCT03410719 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2020-07-17

No results posted yet for this study

Summary

the aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.

Conditions

  • Insulin Sensitivity

Interventions

OTHER

Hi GI

subjects will consume the same quantities of metabolizable CHOs (270 g/d) with 135 g of CHOs assigned to the GI intervention foods. The 135 g of CHOs will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be \<55 (Low-GI group) or \>70 (Hi-GI group).

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER
  • University of Agriculture Science, Uppsala, Sweden

    collaborator UNKNOWN
  • Purdue University

    lead OTHER

Principal Investigators

  • Gabriele Riccardi ([email protected]), M.D · Federico II University

  • Rikard Landberg (rikard.landberg@slu.), Ph.D · Uppsala University, Uppsala, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2020-03-21
Completion
2020-03-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410719 on ClinicalTrials.gov