The Effects of Freeze-Dried Whole Grape Powder on Chronic Disease and Cardiovascular Risk Factors-a Pilot Study

NCT06006182 | Completed

• 2 other identifiers: 10006024-04-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) is responsible for 1 out of every 5 deaths, is the number one killer of Americans, killing about 700K US adults per year (1). Our proposed research is a clinical trial that will determine the effects of feeding California freeze-dried grapes (which are directly comparable to fresh table grapes), on cardiovascular and chronic disease risk factors, namely, blood glucose and lipids (total cholesterol, LDL, HDL, and triacylglycerides), electrolyte and blood indicators (such as sodium, calcium, potassium, etc.), c-reactive protein (hs-CRP) and tumor necrosis factor alpha (TNF-alpha) (measures of inflammation and CVD risk), body composition (body weight, body fat percentage, lean tissue weight, body water amount and Kcal requirement to maintain body composition status), and blood pressure (BP) in 30 adults. The investigators will test satiety and hunger to see if grape antioxidants decrease both, implying that there will be a decrease in caloric intake and result in body composition improvements.

Conditions

Healthy People

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Risk Blood Indicators

  To determine if grape consumption changes (mg/d) fasting blood glucose, total cholesterol, low density lipoproteins, high density lipoproteins, and triacylglycerides

  8 weeks for placebo, 8 weeks for grape arms

Secondary Outcomes (12)

• Body Composition Changes-Percent Body Fat

  8 weeks for placebo, 8 weeks for grape arms

• Body Composition Changes-Body Water

  8 weeks for placebo, 8 weeks for grape arms

• Body Composition Changes-Lean Body Tissue

  8 weeks for placebo, 8 weeks for grape arms

• Inflammatory Factors-C-Reactive Protein

  8 weeks for placebo, 8 weeks for grape arms

• Inflammatory Factors-Tumor Necrosis Factor Alpha

  8 weeks for placebo, 8 weeks for grape arms

Study Arms (2)

Group A-Grape Powder then Placebo

EXPERIMENTAL

Group A block will be the Grape Powder for the first 8 weeks, and then after the washout period, they will begin the Placebo. The experimental Grape Powder is a food-it is simply freeze-dried grape powder

Other: Grape Powder

Group B-Placebo-then Grape Powder

PLACEBO COMPARATOR

Group B block will be the Placebo for the first 8 weeks, and then after the washout period, they will begin the Grape Powder

Other: Grape Powder

Interventions

Grape Powder OTHER

Freeze-dried grape powder

Group A-Grape Powder then Placebo; Group B-Placebo-then Grape Powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apparently healthy adults
• Attend school at or are employed by Cal Poly Pomona
• Not sensitive or allergic to grapes or grape products.
• Must be available 8 weeks during both Fall (2023) and Spring (2024) semesters.

You may not qualify if:

• Do not attend or are not employed by Cal Poly Pomona
• Smokers
• Pregnancy
• Any allergies to or dislike of grapes
• Cross-reactive allergies to grapes such as any of the following: peach, tree nuts, mustard, mulberry, cabbage, figs, kiwi, bananas, melon, apple, cherries, strawberries
• Thyroid disease
• Insulin dependent diabetes
• Non-insulin dependent diabetes
• Cancer
• Cardiovascular diseases
• Body piercings that cannot be removed
• Implanted devices
• Not available for 8 weeks during both (2023) and Spring (2024) semesters.

Sponsors & Collaborators

• California State Polytechnic University, Pomona: lead
• The California Table grape Commission: collaborator

Study Sites (1)

Cal Poly Pomona

Pomona, California, 91768, United States

Location

Related Publications (10)

• 1. Centers for Disease Control and Prevention, National Center for Health Statistics. About Multiple Cause of Death, 1999-2020. CDC WONDER Online Database website. Atlanta, GA: Centers for Disease Control and Prevention; 2022. Accessed January 14, 2023

  BACKGROUND

• 2. Diabetes in Control. New and Information for Medical Professionals. Hyperglycemia Starts at 90mg.dL, That's Right Hyperglycemia. Online website. Accessed January 14, 2023

  BACKGROUND

• Nelson RH. Hyperlipidemia as a risk factor for cardiovascular disease. Prim Care. 2013 Mar;40(1):195-211. doi: 10.1016/j.pop.2012.11.003. Epub 2012 Dec 4.

  PMID: 23402469 BACKGROUND

• 4. Centers for Disease Control and Prevention. CDC 24/7: Saving Lives, Protecting People. Salt. Sodium, Potassium and Health. Online website. Accessed January 14, 2023.

  BACKGROUND

• Arulselvan P, Fard MT, Tan WS, Gothai S, Fakurazi S, Norhaizan ME, Kumar SS. Role of Antioxidants and Natural Products in Inflammation. Oxid Med Cell Longev. 2016;2016:5276130. doi: 10.1155/2016/5276130. Epub 2016 Oct 10.

  PMID: 27803762 BACKGROUND

• 6. National Center for Complementary and Integrative Health (NCCIH). Antioxidants: In Depth. https://nccih.nih.gov/health/antioxidants/introduction.htm. Online website. Accessed January 14, 2023.

  BACKGROUND

• 7. USDA Oxygen Radical Absorbance Capacity (ORAC) of Selected Foods, Release 2 (2010). http://www.orac-info-portal.de/download/ORAC_R2.pdf Accessed January 12, 2024.

  BACKGROUND

• Aune D, Giovannucci E, Boffetta P, Fadnes LT, Keum N, Norat T, Greenwood DC, Riboli E, Vatten LJ, Tonstad S. Fruit and vegetable intake and the risk of cardiovascular disease, total cancer and all-cause mortality-a systematic review and dose-response meta-analysis of prospective studies. Int J Epidemiol. 2017 Jun 1;46(3):1029-1056. doi: 10.1093/ije/dyw319.

  PMID: 28338764 BACKGROUND

• Miller V, Mente A, Dehghan M, Rangarajan S, Zhang X, Swaminathan S, Dagenais G, Gupta R, Mohan V, Lear S, Bangdiwala SI, Schutte AE, Wentzel-Viljoen E, Avezum A, Altuntas Y, Yusoff K, Ismail N, Peer N, Chifamba J, Diaz R, Rahman O, Mohammadifard N, Lana F, Zatonska K, Wielgosz A, Yusufali A, Iqbal R, Lopez-Jaramillo P, Khatib R, Rosengren A, Kutty VR, Li W, Liu J, Liu X, Yin L, Teo K, Anand S, Yusuf S; Prospective Urban Rural Epidemiology (PURE) study investigators. Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study. Lancet. 2017 Nov 4;390(10107):2037-2049. doi: 10.1016/S0140-6736(17)32253-5. Epub 2017 Aug 29.

  PMID: 28864331 BACKGROUND

• 10. Mayo Clinic. Healthy Lifestyle. Nutrition and healthy eating. DASH diet: Healthy eating to lower your blood pressure. Online website. Accessed December 12, 2022.

  BACKGROUND

MeSH Terms

Interventions

whole grape extract

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Researcher

Model Details: The crossover design can differentiate the diet treatment effect from other effects like secular trends and differential carryover, utilizes a perfect control (the experimental subject is the same person as the control), the subjects will experience all treatments (best for subject retention), and this study design does not require very many participants to provide adequate study power. The alpha is set at 0.05, and the power at 80%. Based on the calculations, the required number of participants in order to see a difference is 22. However, since a crossover study assumes a \>20% dropout rate, the minimum of 20% is added to the minimum sample size of 22 at an alpha of 0.05 and a power of 80 (14). Therefore, we will be recruiting 30 adults. Since a parallel design would require 58 per treatment group (total=116), it was determined by the PIs that the crossover design was the best design for this study.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 23, 2023
• Study Start: October 10, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)