Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control, Whole Chickpeas, Puréed Chickpeas, 100% Chickpea Flour Product.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 19 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Daily Consumption of Processed Pulse-based Food Products on Physiological Responses Related to Energy Metabolism and Metabolic Health
Overview
The purpose of this research is to test how processing can affect how one's body uses the nutrients in that food. For this study the researchers are examining how making different food products out of chickpeas, such as hummus or pasta, changes how one's body uses those foods for energy.
Detailed description
The overall objective is to determine the impact of daily consumption of processed pulse-based food products on metabolic health, specifically the physiological responses related to energy metabolism. The primary hypothesis is that consuming a serving of pulses daily for 12 weeks will improve metabolic responses related to energy metabolism, particularly fat oxidation and molecular adaptations related to fat and glucose metabolism, compared to current Dietary Guidelines for Americans (DGA) recommendations. Furthermore, we hypothesize that the degree of processing will influence these metabolic adaptations such that the daily consumption of 100% pulse flour food products will result in the greatest effect on fat oxidation and molecular adaptations related to fat and glucose metabolism followed by the pulse purée which will have a greater effect than the whole cooked pulse (100% pulse flour \> purée \> whole).
Interventions
- Other Control
Participants will consume the Base DGA diet with a standardized non-pulse product snack. - Other Whole Chickpeas
Participants will consume an adjusted DGA diet with a standardized whole chickpea snack. - Other Puréed Chickpeas
Participants will consume an adjusted DGA diet with a standardized puréed chickpea snack. - Other 100% Chickpea Flour Product
Participants will consume an adjusted DGA diet with a standardized 100% chickpea flour product snack.
Primary outcome measures
- Differences in substrate oxidation in response to eating differentially processed pulse-based food products [Time frame: 12 weels]
- Change from Baseline in substrate oxidation after consuming differentially processed pulse-based food products for 12 weeks [Time frame: 12 weeks]
- Determine participant consumption practices and attitudes towards pulse consumption using a validated questionnaire [Time frame: Baseline]
Secondary outcome measures (2)
- Changes in the colonic microbiota in response to consuming differentially processed pulse-based food products [Time frame: 12 weeks]
- Changes in me metabolic gene expression and metabolites in response to consuming differentially processed pulse-based food products. [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- apparently healthy adults
- BMI >18.5 or <35 kg/m2 (healthy body weight - class I obesity)
- ability to understand and sign the consent form
- availability of transportation (i.e., participants must provide their own transportation to the Center)
- non-smoking or do not use other tobacco products, including e-cigarettes
- not taking steroid-based medications
- not planning to or currently attempting to gain or lose weight
- not allergic to study foods
- willing to comply with study demands
Exclusion criteria
- usual pulse consumption greater than DGA recommendation
- inability or unwillingness to consume any of the provided foods
- more than a 10% change in body weight within the past 2 months
- actively trying to lose weight
- pregnancy or actively trying to get pregnant
- lactation
- uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
- HbA1c ≥ 5.7%
- complete blood count (CBC) outside of the normal range for a healthy adult
- history of gastrointestinal (GI) disorders (including Celiac's or Crohn's disease, irritable bowel syndrome, acid reflux, ulcerative colitis, chronic constipation or diarrhea, and lactose intolerance)
- using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids)
- cannot read or understand English
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- USDA Grand Forks Human Nutrition Research Center — Grand Forks
Identifiers
NCT: NCT06758869 · GFHNRC514