Effect of Dried Fruit Intake on Acid-base Balance

NCT ID: NCT04030351

Last Updated: 2020-10-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2020-03-17

Brief Summary

Most adults consume acid-producing diets because their high intake of protein and/or cereal grains in relation to their intake of fruits and vegetables. This study is being done to determine whether acid-base balance can be restored by the addition of dried fruits to the diet. In this study adults with low usual fruit intake will be provided with either 100 g per day of a mix of dried fruits or no dried fruit. Participants will be followed for 1 year. Acid-base status will be assessed by measuring the acid content in 24-hour urine collections.

Detailed Description

Most adults consume acid-producing diets because their intake of protein and/or cereal grains is high in relation to their intake of fruits and vegetables. Supplementation with alkaline salts such as potassium bicarbonate and potassium citrate have been shown to reduce 24-hr urinary net acid excretion (NAE) in healthy adults. This approach requires taking many capsules daily, in split doses after each meal with a full glass of water. An alternative and perhaps more acceptable approach to achieving acid-base balance for most adults may be to modify their diet by increasing intake of alkali-producing foods, such as fruit. Maintaining acid base balance may be important for preserving bone and muscle and renal function and other outcomes but this has not been established. The investigators propose to determine whether adults who are provided with 100 g per day of a selection of dried fruits will actually consume enough of it to correct their acid-producing diets, as evidenced by a lowering of their urinary NAE. The investigators will also determine whether and how participants will alter their overall diets or their body weight when provided with the dried fruit. The comparator group will receive no dried fruit (or other intervention).

Conditions

Acid-Base Balance Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

dried fruit

100 g per day of dried fruit

Group Type: EXPERIMENTAL

food - dried fruit

Intervention Type: OTHER

raisins, apricots, figs, and pineapple

no dried fruit

no intervention to be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

food - dried fruit

raisins, apricots, figs, and pineapple

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• usual self-reported fruit intake not greater than 2.5 servings per day
• adequate dentition to chew dried fruit
• willing to avoid potassium supplements during the study
• willing to avoid antacids other than Pepto Bismol during the study

Exclusion Criteria

Conditions

• diabetes or fasting plasma glucose on screening >125 mg/dl
• untreated thyroid disease
• untreated parathyroid disease
• cirrhosis
• unstable heart disease
• osteoporosis of the spine or hip
• alcohol use > 2 drinks per day
• chronic diarrheal syndrome
• estimated glomerular filtration rate < 50 ml/min
• serum potassium >5.3 meq/L
• abnormal serum calcium
• dysphasia
• malabsorption
• inflammatory bowel disease
• celiac disease
• chronic constipation
• gastric bypass surgery
• non-English speaking Medications
• potassium sparing diuretics
• oral glucocorticoids
• immunosuppressant drugs
• anabolic steroids in last 6 months
• estrogen in last 6 months
• osteoporosis treatment in the last 12 months with teriparatide abaloparatide calcitonin raloxifene denosumab
• osteoporosis treatment with a bisphosphonate in the last 2 years
• regular use of antacids > 3 times per week
• regular use of laxatives > 3 times per week
• any medication taken to alter appetite

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Bess Dawson-Hughes

Director of Bone Metabolism Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2980

Identifier Type: -

Identifier Source: org_study_id