Clinical trial NCT06758869: Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas
Official title: Effects of Daily Consumption of Processed Pulse-based Food Products on Physiological Responses Related to Energy Metabolism and Metabolic Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2025-01-06
Enrollment: 204
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

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

Primary outcomes:
measure: Differences in substrate oxidation in response to eating differentially processed pulse-based food products
timeFrame: 12 weels
measure: Change from Baseline in substrate oxidation after consuming differentially processed pulse-based food products for 12 weeks
timeFrame: 12 weeks
measure: Determine participant consumption practices and attitudes towards pulse consumption using a validated questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Changes in the colonic microbiota in response to consuming differentially processed pulse-based food products
timeFrame: 12 weeks
measure: Changes in me metabolic gene expression and metabolites in response to consuming differentially processed pulse-based food products.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Shanon Casperson
role: PRINCIPAL_INVESTIGATOR
References: