NCT05397028

Brief Summary

A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in \>30% of intervention subjects To assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C remission state without the use of medications by achieving clinically significant weight loss (\>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 8, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

May 25, 2022

Last Update Submit

January 17, 2024

Conditions

ObesityDiabetes Mellitus, Type 2

Keywords

obesityDiabetes, Type 2meal replacementdiabetes remission

Outcome Measures

Primary Outcomes (1)

  • Efficacy of plant-based meal replacement system on A1-C levels

    Blood draw to measure the effect of the diet on the A1-C level. Normal A1C is at or below 5.7%. Prediabetes levels range between 5.8%-6.4%. Diabetes is at or above 6.5%.

    Change between baseline and six month visit.

Secondary Outcomes (1)

  • Efficacy of plant-based meal replacement system on insulin levels

    Change between baseline and six month visit.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Replace meals with a plant-based meal replacement and self-prepared Meditteranean meals for a max 1200 calorie per day. Enroll in a 12 week intensive lifestyle intervention program.

Dietary Supplement: Meal replacement systemBehavioral: Intensive lifestyle Intervention

Standard of Care Group

NO INTERVENTION

Interventions

Meal replacement systemDIETARY_SUPPLEMENT

Participants will replace meals with a meal replacement system to assess the efficacy of weight loss leading to remission of diabetes (optimal A1C levels).

Intervention Group
Intensive lifestyle InterventionBEHAVIORAL

Participants will sign up with a virtual health program which they will interact with.

Intervention Group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and Women
  • Ages 25-65
  • Have been diagnosed with non-insulin dependent diabetes for less than five years
  • Are taking at least one oral agents for diabetes
  • English speaking

You may not qualify if:

  • Individuals currently being treated for cancer
  • Had a myocardial infarction in the previous 3 months
  • Have uncontrolled persistent hypertension - diastolic \>90 systolic \>160
  • Individuals with established eating disorder diagnoses
  • Individuals who have recent weight loss attempt in the last 3 months with \> 5-pound loss
  • Use of anti-obesity medications in the last three months
  • Individuals who have had bariatric surgery
  • Individuals taking medications that are known to cause weight gain including but not limited to insulin, steroids, haloperidol clozapine, risperidone, olanzapine, amitriptyline imipramine, paroxetine, and lithium
  • Individuals who are pregnant or planning to become pregnant in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Warren Peters, MD

    Loma Linda University Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Health Promotion

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

December 8, 2022

Primary Completion

March 14, 2023

Study Completion

March 14, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)