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

NCT05174663 | Completed

• 1 other identifier: 21ABCFA01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the quantity of almonds (1.5 oz or 2.5 oz) consumed as a snack that will provide optimal increases in HDL-C levels.

Conditions

HDL-C; Hypercholesterolemia

Keywords

Hypercholesterolemia; HDL-C; Almond-enriched diet

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 16 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet

  The change from baseline in HDL-C levels at week 16 between Almond-enriched Diet Dose 1 (AD1), Almond-Enriched Diet Dose 2 (AD2), and Nut-Free Diet (NFD) will be determined.

  16 weeks

Secondary Outcomes (77)

• 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

  4 weeks

• 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

  8 weeks

• 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

  12 weeks

• The difference in the proportion of participants from baseline to 4 weeks achieving a clinically relevant increase in HDL-C levels

  4 weeks

• The difference in the proportion of participants from baseline to 8 weeks achieving a clinically relevant increase in HDL-C levels

  8 weeks

Other Outcomes (28)

• Incidence of pre-emergent adverse events following 16-week ingestion of Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, or Nut-Free Diet

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

• Incidence of post-emergent adverse events following 16-week ingestion of Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, or Nut-Free Diet

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

• Change in Aspartate Aminotransferase levels from baseline to 16 weeks following daily ingestion of Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, or Nut-Free Diet

  16 weeks

Study Arms (3)

Almond-enriched diet dose 1

EXPERIMENTAL

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.

Other: Almond-enriched diet - 1.5 oz

Almond-enriched diet dose 2

EXPERIMENTAL

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.

Other: Almond-enriched diet - 2.5 oz

Nut-free diet

OTHER

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.

Other: Control snack

Interventions

Almond-enriched diet - 1.5 oz OTHER

Participants will receive 1.5 oz of almonds consumed as a snack daily for 16 weeks.

Almond-enriched diet dose 1

Almond-enriched diet - 2.5 oz OTHER

Participants will receive 2.5 oz of almonds consumed as a snack daily for 16 weeks.

Almond-enriched diet dose 2

Control snack OTHER

Participants will receive a control snack daily for 16 weeks.

Nut-free diet

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females between 30-65 years of age, inclusive
• BMI between 25.0 - 34.9 kg/m2, inclusive
• Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
• Or,
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Individuals with hypercholesterolemia based on the NCEP definition (LDL-C levels \>4.1 mmol/L (\>160 mg/dL))
• Motivated to comply with dietary guidelines as assessed by a motivation questionnaire at screening
• Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
• Agrees to adhere to dietary guidelines and to maintain current lifestyle habits as much as possible throughout the study depending on the participants' ability to maintain the following: medications, supplements, exercise, and sleep and avoid taking new supplements
• Provided voluntary, written, informed consent to participate in the study

You may not qualify if:

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, or intolerance to the investigational product/control snack ingredients
• Current regular consumption of nuts \>2 times per week, unless willing to washout prior to baseline
• Current use of prescribed lipid lowering medications as assessed by QI (see Section 7.3.1)
• Current use of over-the-counter medications or supplements known to affect blood lipid levels (i.e. omega-3) or vitamin E status
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by QI
• Type I or Type II diabetes
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Individuals with an autoimmune disease or are immune compromised as assessed by QI
• Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
• Self-reported confirmation of blood/bleeding disorders as assessed by QI

Sponsors & Collaborators

• Almond Board of California: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A5R8, Canada

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The dietary interventions in this proposed study prevent blinding as it is impossible to mask the participant and investigators to whether the participants are consuming whole almonds or not. The requirements to report the quantity of almonds consumed also precludes blinding for both the participant and investigator. The statistician will be blinded for the duration of the study and throughout all analysis and reporting. The preclusion of blinding in this study is not a limitation given the objectivity of the primary and most secondary endpoints. This is a well-controlled study design that provides a "real-world" assessment of the dietary interventions that bolsters the resulting data to withstand scientific and regulatory scrutiny.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 3, 2022
• Study Start: January 10, 2022
• Primary Completion: November 18, 2023
• Study Completion: November 18, 2023
• Last Updated: January 30, 2024

Record last verified: 2023-01

Locations

CA (1)