← Back to Search

Other

Powdered Meal Replacement for Dietary Modifications (PREMIUM Trial)

N/A

Waitlist Available

Led By Arya Sharma, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).

Awards & highlights

PREMIUM Trial Summary

This trial will investigate the impact of a 12-week powdered meal replacement on various markers related to obesity, including inflammation, metabolism, hormones, and the composition of gut microbiota.

PREMIUM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interleukin-6.

Secondary outcome measures

Gut microbiota diversity and composition.

Other outcome measures

Adiponectin.

Appetite sensations.

Blood Glucose

+18 more

PREMIUM Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Powdered Meal Replacement GroupExperimental Treatment1 Intervention

Those assigned to the Powdered Meal Replacement group will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).

Group II: Control GroupActive Control1 Intervention

Those assigned to the Control group will be asked to maintain their usual dietary intake over 12 weeks. Participants' usual dietary intake is expected to reflect the North American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from carbohydrate and ~35% from fat).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Soy protein, honey and yogurt.

2019

N/A

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,046 Total Patients Enrolled

3 Trials studying Dietary Modifications

305 Patients Enrolled for Dietary Modifications

Almased Wellness GmbHIndustry Sponsor

5 Previous Clinical Trials

459 Total Patients Enrolled

2 Trials studying Dietary Modifications

47 Patients Enrolled for Dietary Modifications

Arya Sharma, PhDPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Dietary Modifications

20 Patients Enrolled for Dietary Modifications

Media Library

Powdered Meal Replacement (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03235804 — N/A

Dietary Modifications Research Study Groups: Powdered Meal Replacement Group, Control Group

Dietary Modifications Clinical Trial 2023: Powdered Meal Replacement Highlights & Side Effects. Trial Name: NCT03235804 — N/A

Powdered Meal Replacement (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03235804 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participation in this medical experiment?

"This medical trial is attempting to recruit 88 subjects aged 18-50, who maintain particular dietary habits. To be eligible for the study, female participants must confirm use of an effective form of birth control (abstinence, hormonal contraception [oral or injectable], IUDs, confirmed vasectomy in partner etc.), while male and female applicants should not smoke tobacco products and have a Body Mass Index between 25-37 kg/m² as well as stable weight within 5 kilograms over the last 6 months. Additionally, fat mass needs to exceed 20% in men and 25% in women with continual levels of physical activity throughout duration of experiment."

Answered by AI

Are geriatric individuals excluded from the purview of this research study?

"This clinical trial mandates that potential participants be older than 18 and younger than 50 years old."

Answered by AI

What is the sample size of this medical experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour is still in search of participants after its initial post date on April 1st 2019 and last update from June 29th 2022. Recruitment for the trial will involve 88 patients spread across one location."

Answered by AI

Is there a possibility to join the clinical trial at this moment?

"Indeed, the clinical trial is currently open for enrollment. The study was first published on April 1st 2019 and its most recent update occured on June 29th 2022. 88 participants are required from a sole research institution."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota

Carla Prado 2019. "The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03235804.