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Nut-free diet for High Cholesterol

N/A

Waitlist Available

Led By David Crowley, MD

Research Sponsored by Almond Board of California

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 16 weeks and at a 7-day follow-up at the end of the study

Awards & highlights

Study Summary

This trial will study how many almonds people need to eat to raise their HDL-C levels.

Eligible Conditions

High Cholesterol
High-Density Lipoprotein

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks and at a 7-day follow-up at the end of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks and at a 7-day follow-up at the end of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks and at a 7-day follow-up at the end of the study for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Cocaine

Secondary outcome measures

Change from baseline to week 12 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet

Change from baseline to week 4 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet

Change from baseline to week 8 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet

+74 more

Other outcome measures

Aspartate Transaminase

Change in Red Blood Cell (RBC) Count from baseline to 16 weeks following daily ingestion of Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, or Nut-Free Diet

Alanine Transaminase

+25 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Nut-free dietExperimental Treatment1 Intervention

Participants will be instructed to ingest the control snack (Iso-caloric [to 1.5 oz of almonds] control snack of chocolate chip cookies or Oreo cookies) daily for 16 weeks. The control snack can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of snack daily. If a dose is missed, participants should take the missed dose as soon as the participants remember.

Group II: Almond-enriched diet dose 2Experimental Treatment1 Intervention

Participants will be instructed to ingest 2.5 oz of almonds daily for 16 weeks. The 2.5 oz of almonds can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of almonds daily. If a dose is missed, participants should take the missed dose as soon as the participants remember.

Group III: Almond-enriched diet dose 1Experimental Treatment1 Intervention

Participants will be instructed to ingest 1.5 oz of almonds daily for 16 weeks. The 1.5 oz of almonds can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of almonds daily. If a dose is missed, participants should take the missed dose as soon as the participants remember.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Almond Board of CaliforniaLead Sponsor

33 Previous Clinical Trials

1,996 Total Patients Enrolled

KGK Science Inc.Industry Sponsor

78 Previous Clinical Trials

6,085 Total Patients Enrolled

David Crowley, MDPrincipal InvestigatorKGK Science Inc.

35 Previous Clinical Trials

2,678 Total Patients Enrolled

Frequently Asked Questions

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

Does this trial encompass individuals beyond the age of 30?

"This study seeks participants aged between 30 and 65."

Answered by AI

To what extent has this clinical trial been populated with participants?

"Indeed, clinicaltrials.gov indicates that this research study is currently searching for enrollees. The trial was initially listed on January 18th 2022 and updated most recently on February 10th 2022, requiring 75 individuals to take part at one site."

Answered by AI

Is this research initiative currently open to new participants?

"Affirmative. Clinicaltrials.gov offers evidence that this clinical trial is still actively recruiting patients, having first been posted on the 18th of January 2022 and amended most recently on February 10th. The study requires 75 participants to be sourced from a single site."

Answered by AI

How may I become a participant in this scientific experiment?

"Prospective participants of this clinical trial must have hypercholesterolemia and be aged between 30 to 65 years old. 75 people will be accepted into the study overall."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating the Dose Response of an Almond-enriched Diet on Optimizing HDL-C in a Population With Hypercholesterolemia

2022. "Investigating the Dose Response of an Almond-enriched Diet on Optimizing HDL-C in a Population With Hypercholesterolemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05174663.