RCT Protocol for Mediterranean vs Low-Carbohydrate Diets in Northern Lebanon

Northern Lebanon is the location for this protocol describing a two-phase, multi-center randomized controlled trial involving 50 adults with type 2 diabetes. Janot J. Ayoub authored this document outlining a 12-month study comparing low-calorie Mediterranean and low-carbohydrate diets for diabetes remission. The protocol was last updated on April 8, 2026, and is registered with the ISRCTN clinical trials database.

Use Cases

• Analyzing the Intervention Mapping protocol steps used to design the 6-month weight loss phase for behavioral change.
• Comparing primary outcome definitions for diabetes remission, specifically HbA1c levels below 6.5% with or without medication discontinuation.
• Reviewing secondary outcome measures including weight, body composition, lipid profiles, sleep quality, and inflammatory markers assessed at baseline and 3-month intervals.
• Studying the integration of mobile health application support during the 6-month maintenance phase of the trial.

Strengths

• Protocol is registered with a clinical trials database (ISRCTN99204002), providing a public record.
• Clearly defines a 12-month follow-up duration with specific 6-month weight loss and 6-month maintenance phases.
• Specifies a sample size of 50 participants with inclusion criteria (age 18-65, diabetes duration ≤6 years, on oral medications).

Limitations

• The dataset is a 24.1 KB DOCX file containing only the study protocol, not the actual trial results or participant data.
• Sample size is limited to 50 participants, which may restrict the statistical power for some secondary outcomes.
• Geographic scope is restricted to primary medical centers in Northern Lebanon, limiting generalizability.

Provenance

Source

figshare, authored by Janot J. Ayoub.

Collection Method

Document describes a planned randomized controlled trial protocol developed using the Intervention Mapping framework.

Time Range

The protocol describes a planned 12-month study; the document itself was posted/updated in 2026.

Freshness

Protocol document was last updated on 2026-04-08.

Geography

Primary medical centers in Northern Lebanon.