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Completed

NCT Number: NCT04692298

Effects of Pulse Consumption on Bone Health of Postmenopausal Women

This study will investigate the effects of the addition of 100 grams/day of cooked pulses (i.e. lentil, pinto beans, peas, chickpeas, kidney beans) to the diet of postmenopausal women for 12 weeks on gut health, metabolic outcomes and bone biomarkers.

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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nutritional Sciences Department, Oklahoma State University

Stillwater, Oklahoma, 74078, United States

About this study

With approximately 1.3 million women reaching menopause each year in the US and about one-third of a woman's life is spent in this state, it is imperative to identify effective, safe, and economical approaches that can minimize disease risk that is associated with this phase of life. Pulses are excellent source of fiber, protein, essential amino acids, vitamins, minerals and phytochemicals, that can act as prebiotics and prevent gut dysbiosis and promote a healthy gut. A few studies in overweight or obese adults have shown the health benefits of pulses, including gut modulating potential. However, studies examining the use of pulse crops are limited, especially in alleviating health risks associated with menopause. The objective of this study is to evaluate the prebiotic potential of pulse-based diet and consequent effects on metabolic and bone biomarkers in postmenopausal women. We hypothesize that daily intake of pulses, due to its nutrient content and many other bioactive compounds including fiber content, will beneficially affect gut health and subsequently improve metabolic outcomes and bone markers in postmenopausal women. To accomplish our objectives, 40 postmenopausal women (50- 65 y old and ≥ 1 y menopause) will be recruited and will be asked to consume 100 g/d of pulse (alternate between lentils, pinto beans, peas, chickpeas, and kidney beans) for 3 months. Pulse intake, anthropometric measures, markers of gut and bone health, and metabolic outcomes will be assessed at baseline and at the end of pulse consumption.

Once the study was underway and we got more funding, women were given the option to continue pulse supplementation for another six months to examine changes on bone density.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1 year without menstrual cycle

Exclusion criteria

  • any medication use (for the past 6 m) that affects glucose, lipids, bone and inflammation markers, dietary supplements, and non-steroidal anti-inflammatory medications
  • allergy to pulse crops
  • tobacco use
  • excessive alcohol intake
  • antibiotic use
  • major surgery within 6 m of study enrollment

Treatment and study plan

Pulses

Other

kidney beans, pinto beans, lentil, black-eyed pea and chickpea

Primary outcomes

  1. changes in blood biomarkers and/or bone mineral density (BMD)

    Time frame: change from baseline, after 90 days and 9 months (for BMD)

    analyzed by enzyme linked immunoassay or dual energy xray absorptiometry for BMD

  2. blood C-terminal telopeptide of type 1 collagen (CTX)

    Time frame: change from baseline after 90 days

    analyzed by enzyme-linked immunoassay

  3. blood procollagen type 1 N-propeptide (P1NP)

    Time frame: change from baseline after 90 days

    analyzed by enzyme-linked immunoassay

  4. fecal bacteria

    Time frame: change from baseline after 90 days

    analyzed by 16sRNA sequencing

  5. fecal short chain fatty acid

    Time frame: change from baseline after 90 days

    analyzed by gas chromatography

  6. fecal immunoglobulin A

    Time frame: change from baseline after 90 days

    analyzed by enzyme-linked immunoassay

  7. plasma concentrations of fatty acid binding protein

    Time frame: change from baseline after 90 days

    analyzed by enzyme-linked immunoassay

Secondary outcomes

  1. fasting blood glucose

    Time frame: change from baseline after 90 days

    analyzed using clinical chemistry analyzer

  2. blood glycosylated hemoglobin

    Time frame: change from baseline after 90 days

    analyzed using clinical chemistry analyzer

  3. blood insulin

    Time frame: change from baseline after 90 days

    analyzed using enzyme linked immunoassay

  4. blood C-peptide

    Time frame: change from baseline after 90 days

    analyzed using enzyme linked immunoassay

  5. blood total cholesterol

    Time frame: change from baseline after 90 days

    analyzed using clinical chemistry analyzer

  6. blood HDL cholesterol

    Time frame: change from baseline after 90 days

    analyzed using clinical chemistry analyzer

  7. blood LDL cholesterol

    Time frame: change from baseline after 90 days

    analyzed using clinical chemistry analyzer

  8. blood triglycerides

    Time frame: change from baseline after 90 days

    analyzed using clinical chemistry analyzer

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Collaborators

  • USDA Beltsville Human Nutrition Research Center

Registry information

Official study title

Pulse Consumption Improves Gut Health, Metabolic Outcomes, and Bone Biomarkers of Postmenopausal Women

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 31, 2020
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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