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Diet Composition for Weight Loss (POINTS Trial)

N/A
Waitlist Available
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights

POINTS Trial Summary

This trial will test whether a person's genetic code affects how much weight he/she will lose on a diet that either has more carbohydrates or more dietary fat.

Who is the study for?
This trial is for individuals with a BMI between 27.0 and 47.5 who are identified as 'fat responders' or 'carbohydrate responders' based on their genetic risk score from a genealogy test. It's not suitable for those who've had significant weight changes recently, smokers, pregnant women, or people with conditions affecting body weight or metabolism.Check my eligibility
What is being tested?
The study aims to determine if genetics influence weight loss effectiveness when following diets high in carbohydrates versus high in fats. Participants will be randomly assigned to one of the two diet groups based on their genetic predisposition ('Carbohydrate responder' or 'Fat responder').See study design
What are the potential side effects?
Since this trial involves dietary interventions rather than medications, side effects may include typical diet-related issues such as gastrointestinal discomfort, changes in energy levels, and potential nutrient deficiencies depending on individual responses.

POINTS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 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
Percent Weight Change
Weight Change
Secondary outcome measures
Change in Cognitive Restraint
Change in Disinhibition
Change in Fat Preference Index
+3 more

POINTS Trial Design

4Treatment groups
Experimental Treatment
Group I: Fat responders (2)Experimental Treatment1 Intervention
receiving high-carbohydrate diet
Group II: Fat responders (1)Experimental Treatment1 Intervention
receiving high-fat diet
Group III: Carbohydrate responders (2)Experimental Treatment1 Intervention
receiving high-carbohydrate diet
Group IV: Carbohydrate responders (1)Experimental Treatment1 Intervention
receiving high-fat diet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High-fat diet
2014
N/A
~240
High-carbohydrate diet
2015
N/A
~210

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
304 Previous Clinical Trials
181,291 Total Patients Enrolled
23 Trials studying Weight Loss
103,286 Patients Enrolled for Weight Loss
Weight Watchers InternationalIndustry Sponsor
22 Previous Clinical Trials
5,056 Total Patients Enrolled
5 Trials studying Weight Loss
890 Patients Enrolled for Weight Loss

Media Library

High-carbohydrate diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04145466 — N/A
Weight Loss Research Study Groups: Carbohydrate responders (1), Carbohydrate responders (2), Fat responders (2), Fat responders (1)
Weight Loss Clinical Trial 2023: High-carbohydrate diet Highlights & Side Effects. Trial Name: NCT04145466 — N/A
High-carbohydrate diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04145466 — N/A

Frequently Asked Questions

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

Are there any vacancies left for participants in this research?

"According to information hosted on clinicaltrials.gov, this research initiative is no longer recruiting participants. The study was first published in February of 2020 and the last update happened September 15th 2022. Despite being closed for enrollment, there are 223 other studies actively seeking out candidates at present."

Answered by AI

Does this medical study restrict its participants to a certain age range?

"This research endeavour is seeking participants aged 18+ and under 75 years old."

Answered by AI

Who is eligible to take part in this experiment?

"Patients aged between 18 and 75 with a BMI of 27.0 - 47.5 kg/m2 are recruited for this trial, amounting to 154 individuals in total. The eligibility criteria also requires that they be either fat responders or carbohydrate responders as determined by genetic risk score; it is estimated that around 1/3 of people fit into each category while the remaining third may respond to either diet type."

Answered by AI

What is the ultimate outcome that researchers are hoping to accomplish with this medical experiment?

"The clinical trial sponsor, Weight Watchers International, has declared that the primary metric to be evaluated during this Baseline to 12 week period is Percentage Body Mass Change. Secondary outcomes being monitored include Transformation of Fat Preference Index (measured using Food Preference Questionnaire), Variation in Food Cravings (assessed via a 33-item inventory) and Modification of Waist Circumference."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
How old are they?
18 - 65
What site did they apply to?
Pennington Biomedical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Personalized Nutrition Study
Corby K. Martin 2020. "The Personalized Nutrition Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04145466.
~29 spots leftby Apr 2025
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